Product Insert:
Avanta MCP Finger Prosthesis
Product Insert:
HUMANITARIAN DEVICE. The AvantaMCP Finger Prosthesisis authorizedby Federal law for usein arthroplastyof the MCPjoint wheneither the:
patientis in needof a revision of failed MCP prosthesis(es);or patient expects to place his/her handsunder loading situations,which preclude the use of an alternativeimplant in the painful osteo-arthriticand posttraumatic arthritic MCPjoint.
The effectivenessof this device for this usehas not beendemonstrated
CAUTION
Federal (United States) law restricts this device to sale, distribution and use by or on the order of a physician.
DESCRIPTION
The AvantaMCP Finger Prosthesisconsists of a distal componentwhich is madeof an ultra-high molecularweight polyethylene(UHMWPe) articulatingsurface and stem,and a proximal component consistingof a cobalt-chromium-molybdenumarticulating surface. Thejoint prosthesisis intendedfor use with bonecement. The device is semi-constrainedbecause it limits translationand rotation of the prosthesisin one or more planesvia the geometryof its articulatingsurfaces. It hasno across-the-joint linkage. The two componentsof the implantarticulate on their matingsurfaces.
The proximal componentis designedfor implantationonto the distal end of the metacarpal.The distal componentis designedfor implantationinto the proximal end of the proximal phalanx.Both components are intendedto articulateon eachother allowing for 90 degreesof flexion/extens ion. The articular surfaces preventdislocation of the joint throughsimulation of the naturaljoint implantarticular surface.Both the proximal and distal componentsare designedto beused with cement.
The implant is available in five sizes. An alpha-numericcoding systemis usedto distinguishsizes. A full surgical instrumentset with appropriatelysized trials andbroaches is available.
Materials: 0 ASTM F-648ultra-high molecular weight polyethylene (UHMWPe) distalcomponent 0 ASTM F75 cobaltchromium proximal component INDICATIONS
The Avanta MCP Finger Prosthesis is indicated for use in arthroplasty of the MCP joint when either the:
" patient is in need of a revision of failed MCP prosthesis(es); or " patient expects to place his/her hands under loading situations which preclude the use of an alternative implant in the painful osteo-arthritic and post traumatic arthritic MCP joint.
CONTRAINDICATIONS
or prior " Bone, musculature, tendons, or adjacent soft tissue compromised by disease, infection, implantation, which cannot provide adequate support or fixation for the prosthesis. " Infection. " Skeletal Immaturity.
WARNINGS (See also the Patient Counseling Information Section)
Strenuous loading, excessive mobility, and articular instability all may lead to accelerated wear and eventual failure by loosening, fracture, or dislocation of the device. Patients should be made aware of the increased potential for device failure when excessive demands are made upon it.
PRECAUTIONS
" Do not resterilize. The implant is provided sterile. If either the implant or the package appears damaged, the expiration date has been exceeded, or if sterility is questioned for any reason, the implant should not be used. " Meticulous preparation of the implant site and selection of the proper size implant increase the potential for a successful outcome. " The implant should be removed from its sterile package only after the implant site has been prepared and properly sized. " Implants should be handled with blunt instruments to avoid scratching, cutting or nicking the device.
ADVERSE EVENTS
REPORTED ADVERSE EVENTS
There has been some clinical experience with this device. In the US, 20 patients have been implanted with the device with a maximum length of follow-up of 24 months. In the US patients, the most commonly reported adverse events were:
" post operative pain " subluxation " dislocation
For more details see Table 5: Complications for US Patients in the Clinical Experience Section for reported adverse events associatedwith the device.
POTENTIAL ADVERSE EFFECTS
General Surgery Related Risks " bleeding " infection " loss of use of the hand " permanentdisability " death
Joint ReplacementRelated Risks " pain " injury to surroundingnerves, blood vessels,tendons or soft tissue " stiffness " night and weatherrelated pain " loss of motion " implant fracture " rotation of implant " acceleratedwear of the devicecomponents " looseningof the implant from the bones " instability of the joint " dislocationof thejoint " cementextrusion injury " infection " lengtheningor shorteningof the finger " amputation " bone weakeningaround the implant " decreasein rangeof motion " allergic or other reactionsto the metalor plastic materials " additional surgerymay berequired for reoperation,revision or fusion of the joint " surgerymay be startedbut a joint replacementcannot be doneresulting in fusion of thejoint " Notification in accordancewith the California SafeDrinking Water andToxic EnforcementAct of 1986(Proposition 65): This productcontains a chemical(;)known to the Stateof California to cause cancer,and/or birth defectsand otherreproductive toxicity.
12- CLINICAL EXPERIENCE
Therehas been some clinical experiencewith this device. In the US, 20 patientshave been implanted with the Avanta MCP Finger Prostheseswith a maximumlength of follow-up of 24 monthsin a prospective randomizedclinical study. Patientsare randomizedinto eitherthe experimentalgroup, which receivedthe Avanta MCP FingerProsthesis, or into the controlgroup, which receiveda siliconeelastomer implant. Thirty-four patientshave been randomized into the study to date. Howeveronly 29 of thesepatients, 20 experimentaland 9 control, havehad surgeryperformed to implanteither the controldevice or the Avanta MCP Finger Prosthesis.Table 3 describesthe patientsrandomized into the study, patientsimplanted with a device and the patientdropouts from the study. Twenty nine of thesepatients have follow-up data,which is summarizedin Tables4-6. Tables4-6 describethe patientdemographics, reported complications and lengthof follow-up for this clinical study to date. Table 3. US PatientsMCP I PatientCategory Patientswith Patientswith Total AvantaMCP SiliconeImplant (patients/hands) implant(patients) (patients/hands) Total Randomizedinto Study 20 14/15 34/35 Total WhoHave Had Surgery 20 9/10 29/30 WithdrewPrior to Surgery 0 5 5 WithdrewAfter Surgery 5 2 7 Data* With follow-up 20 9/10 29/30 Datareport forms have been returned on29 patients. Tables4-6 describe theclinical results for these 29 patients.
Table4. Demographicsfor 29 US Patients*with Follow-up Category Patientswith Avanta MCP Patientswith Silicone Total Implant Implant Male 3 1 4 Female 16 8 24 Unknown 0 1 1 MeanAge, SD 56.3±11.3(n=19) 61.9±8.1 (n=6) 58.2±10.3 AgeRange (years) 32-77 52-74 32-77 Osteo-arthritis 1 1 2 Polymytosis 0 1 1 RheumatoidArthritis 18 7 25 SiliconeImplant Revision 1 0 1 *Descriptionof number of patientswith more than one implant. There are 29 patients with 99 implants:twenty patients with 4 implants;three patients with 3 implants;three patients with 2 implants;four patients with I implant.
Table5. Cowlications for US Patients Complication AvantaMCP Device(n=8 SiliconeDevice (n=O Patients) Patients) SkinNecrosis 1 0 WoundDehiscence 1 0 ImplantFailure 1 0 JointDislocation 3 0 JointSubluxation 4 0 pain(6 months_post-qp)_ 4 0 Table 6. Numberof US Patients(Implants) at Eachfollow-up Time Point Lengthoffollow-up AvantaMCP Implant SiliconeImplant Patients(# implants) Patients(# implants) Post-op(1-4 weeks) 20(68) 9(31) 3 months 18(61) 8(29) 6 months 16(53) 6(21) 12 months 9(32) 2(12) 24 months 4(14) 2(5) Post-ovwithdrawal 5(20) 2(5)
Linscheid' reportedon sixty-onefingers in 25 patientstreated with this device. Eight implantswere implantedin eightpatients with traumaticor degenerativearthritis. Fifty-three implants were implantedin 17 patientswith rheumatoidarthritis. Therewere 23 womenand 2 men,with an averageage of 63 years (range = 45-78 years). The averagepreoperative MCP arc of motionwas 45 degrees,with an extension lag averaging45 degrees.Preoperatively, there was an averageof 20 degreesof u1nardeviation. deformitieswere common in thosepatients with rheumatoidarthritis. Swan-neck = traumaticor The follow-upaveraged 30 months(range 4-60 months).The resultsin singlejoints with degenerativearthritis were better than in the multiplefingers with rheumatoidarthritis. The averagearc of motionwas 50 degrees(range 25-90 degrees).Extension lag was improvedin the rheumatoidpatients. The authorstated, "Grip and pinchstrength showed little change,but discomfortwas noticeablybetter subjectively."The author reported"Subluxation or dislocationrecurred despite repair of the collateral only tendon." ligamentsand recenteringof the extensor The reportdid not providethe rate of theseadverse events.The authorstates that this complication was addressed through postoperative splinting, or casting, andcareful monitoring of jointreduction through the useof x-ray.
/ 1Y SURGICAL PROCEDURES
A manual is available describingdetailed surgical proceduresfor use of these implant devices. It is the it responsibilityof the surgeonto be familiar with the procedurebefore use of theseproducts. In addition, is the responsibility of the surgeonto be familiar with relevantpublications and consult with experienced associatesregarding the implant proceduresbefore use.
PATIENT COUNSELING INFORMATION (Seealso Warnings)
A patient brochureis availablefor usein counselingthe patient.
In addition to the patient related information containedin the Warningsand Adverse Eventssections, the following informationshould be conveyedto the patient:
" While the expectedlife of total joint replacementcomponents is difficult to estimate,it is finite. These componentsare made of foreign materials, which are placed within the body for the potential restorationof mobility or reduction of pain. However, due to the many biological, mechanicaland physiochemicalfactors which affect thesedevices, the componentscannot be expected to withstandthe activity level and loads of normal healthybone for an unlimitedperiod of time.
" Adverseeffects of this devicemay necessitatereoperation, revision, or fusion of the involvedjoint.
STERILIZATION
This componenthas been sterilized by ethyleneoxide or gammaradiation. Do not resterilize. The implant is provided sterile. If either the implant or the packageappears damaged,the expirationdate has been exceeded, or if sterility is questionedfor any reason,the implant shouldnot be used. Trial sizer componentsare available to avoid having to open the sterile packageprior to prosthesis implantation. The implant shouldbe removed from its sterile packageonly after the implant site has beenprepared and properlysized.
LIMITED WARRANTY
Avanta OrthopaedicsInc., warrantsthat this product meetsthe manufacturer'sspecifications and is free from manufacturingdefects at the time of delivery. This warranty specifically excludesdefects resulting from misuse,abuse or improperhandling of the product subsequentto receipt by the purchaser. Avanta Orthopaedicsdoes not warrantthe outcomeof the surgicalprocedure.
EU Representative: 19-Oxxxrev. A Michael's France,55 Avenue Sainte-Foy,92200 Neuilly Sur Seine,Paris, France (33) 146 37 66 65
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1-5 PatientLabeling Brochure
dorsalview
cr: distal proximal
lateralview
Photographor drawingof the implant
What is the purpose of the (MCP) Joint prosthesis?
HUMANITARIAN DEVICE. The Avanta Metacarpophalangeal(MCP) Finger Prosthesisis authorizedby Federallaw for usein arthroplasty(surgery) of the MCP joint wheneither the:
" patientneeds the surgeryagain because a previousjoint surgeryfailed. " patientexpects to usehis/her hand under heavyloading (doing heavylifting) and othertypes of devicesare not usefulfor this purpose.
The effectivenessof this devicefor this usehas not beendemonstrated.
When should the device not be used?-- Contraindications
" Whenyour bone,musculature, tendons, or adjacentsoft tissueis damagedby disease, infections or by prior implantation. " Infection " When you do not haveadequate skeletal support for the implant. " When you are youngand your bonesare still growing.
What is my doctor thinkine about usinE for my implant?
0 Avanta Orthopaedicshas developed an implant for the Metacarpophalangeal(MCP) finger joint. The (MCP)joint is thejoint that is alsoreferred to as your knuckle.
/6 " This implant is availablefor salein the United Statesas a humanitarianuse device. A humanitarianuse device is one,which is usedfor conditionsor diseaseswhich typically affect fewer than 4000 peoplein the United Statesper year, andwhen there is no comparabledevice marketedto treat/diagnosethose conditions or diseases. " Your physicianhas determined that you may benefitfrom implantationof this finger joint implant. " You should be aware that the effectivenessof this device for this use has not been demonstrated.
What will occur duriney the sumery?
" This surgeryinvolves the useof a fingerjoint replacementdevice for treatmentof patientswith certainkinds of arthritis (osteo-arthritisor post traumaticarthritis) and who expectto placetheir handsin heavyloading situations,or patientsneeding revision of a failed implantplaced in the MCP joint. " A joint replacementsurgery is an operationwhere the arthritic joint is removedand a metal and plasticjoint is insertedto replacethe naturaljoint. The surgeryis expected to last about2 hours. " The procedureis done in the operatingroom and requiresgeneral anesthesiaor an axillary block. (Generalanesthesia effects the entire body and is accompaniedby a loss of consciousness.An axillary block resultsin anesthesiaof the handand forearm only. A tourniquetis appliedto the arm to preventbleeding during the surgery.) " In joint replacementsurgery, your hand is openedat the finger joint, and the bones are trimmed. The metal and plasticjoint replacementparts are fixed to the bones using bonecement.
Will there be special care after the surj!erv?
" Antibiotics areusually given during and after the operationto preventinfection, as is normal in thesecases, with currentsurgical treatment. " Your doctor may give you medicinefor pain after surgery. " After the operation,your handwill be in a bandage.This will be removedtwo to five days following the operation.You may need to wear a splint or a cast for up to 4 weeks. " Whenthe bandageor splint is removed,you will start physicaltherapy. " Your doctor and therapistwill tell you how to take care of your hand. It is very importantto follow their instructionsand attend all of your appointments.
Are there Warnines I should be aware or
It is unlikely that your finger joint will be restoredto the conditionit was before your injury, arthritis or previous surgery. You should discussyour expectationsof having surgerywith your doctor beforehaving surgery,as this proceduremay not meet your expectations.
Iq You should be aware that strenuous loading, excessive mobility, and articular instability all may lead to accelerated wear and eventual failure by loosening, fracture, or dislocation of the device. There is an increased potential for device failure when excessive demands are made upon it.
Does this sumery have risks that I should be aware or
Note: It is important that you discuss all of these risks with your doctor.
General Surgery Related Risks - These are problems you may have because you are having surgery.
9 bleeding 0 infection 0 loss of use of the hand 0 permanent disability 0 death
Joint Replacement Related Risks - These are problems you may have because you are having this implant placed in your hand.
0 pain 0 injury to surrounding nerves, blood vessels, tendons or soft tissue (e.g., numbness) 0 stiffness 0 night and weather related pain 0 loss of motion 0 implant fracture 0 rotation of implant 0 acceleratedwear of the device components loosening of the implant from the bones 0 dislocation of the joint 0 cement protrusion injury 0 infection 0 lengthening or shortening of the finger a amputation 0 bone weakening around the implant 0 decreasein range of motion 0 allergic or other reactions to the metal or plastic materials 0 additional surgery may be required for reoperation, revision or fusion of the joint 0 surgery may be started but a joint replacement cannot be done resulting in fusion of the joint 0 Notification in accordancewith the California Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65): This product contains a chemical(s) known to the Stateof California to causecancer, and/or birth defectsand other reproductivetoxicity.
What Benefits may I hope to receive?
improvedrange of motion relief of pain improvedgrip andpinch strength.
Are there other treatments that I could receive for my condition?
You shouldthoroughly discuss the options for treatingyour fingerjoint with your doctor beforeselecting surgery as an alternative. Arthritis of the MetacarpophalangealJoint can be treatednon surgically or with surgery. The non surgical options include the use of splints,joint injectionsand medications (including the useof aspirintype drugs).
Currentsurgical treatments include fusion of the bonestogether, surgery on the joint with tendon or joint replacementwith silicone implants. Joint replacement,with silicone implants has been available for a number of years and has the advantagesof relieving pain and allowing motion at the joint. Someof the risks of silicone implants includethe possibility for breakage,deformation, and side to side instability. If you are very active anduse your handsheavily, you may not be good candidatesfor siliconeimplants.
What can I expect after surgery?
You shouldbe aware,all implants will wear over time with use. It is important that you ask you surgeonwhat range of motion you may hope to have after the surgeryand what strength you may hope to regain These factors will vary from one patient to another Therefore some degree of wear particle formation is inevitable with all implants including those madeof silicone. The patient'sbiological responseto theseparticles is variable. There are also reports in the medical literature suggestinga possible link betweensilicone implants and immunologicalabnormalities and autoimmunerheumatic disorders.
Glossary
Amputation- The removal of your entire finger or limb.
Antibiotics- Medication used to treatinfection caused by bacteriaand other microorganisms.
AxillaryBlock - A typeof anesthetic, which numbs only the hand and forearm. You stay awakeduring the surgery with this type of anesthesia.
Immunologicalabnormalities - A conditionwhich results ininadequate or ineffective functioningofyour bodies immune system.
If Instability - The joint doesn't provide enoughsupport to resist your activities and may slide off to the side.
Metacarpophalangeal(MCP) fingerjoint - Commonlyreferred to as your knuckle.
Revision Surgery- A joint or implant may needmore than one surgeryif the first surgery doesn't work as well as expected.
Therapist- A personwho will help you care for your hand after surgeryto give you the bestresult possible. This personworks with your doctorto treatyour hand.
19-Oxxxrev. A
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