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