BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK KNEE COMPONENTS

    MDR report key: 20558301 · Received October 29, 2024

    Report

    Report Number
    1038671-2024-04162
    Event Type
    Injury
    Date Received
    October 29, 2024
    Date of Event
    December 9, 2021
    Report Date
    November 11, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    D1: UPDATED: D10 CONCOMITANT DEVICES: (B)(6), 200-04-33 - CEMENTED FINNED TIB. TRA SZ 3F/3T, (B)(6), 234-02-03 - OPTETRAK ASY, PS CEMENTED FEMORAL, SZ 3, (B)(6), 200-02-35 - THREE PEG PATELLA 35MM, (B)(6), 200-02-35 - THREE PEG PATELLA 35MM, (B)(6), 200-04-33 - CEMENTED FINNED TIB. TRA SZ 3F/3T, (B)(6), 234-03-03 - OPTETRAK ASY, PS CEMENTED FEMORAL, SZ 3, H6: CORRECTED HEALTH EFFECT - TYPE OF INVESTIGATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, INSTABILITY, AND LOOSENING. ADDITIONALLY, THESE DEVICES APPEAR TO HAVE BEEN IMPLANTED FOR OVER TEN YEARS PRIOR TO THE REPORTED EVENT. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 143 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING, AND INSTABILITY. UPON REVISION OF THE EXACTECH DEVICE, PLAINTIFF'S SURGEON OBSERVED SIGNS OF PROSTHETIC LOOSENING DUE TO GROSS POLYETHYLENE WEAR AND OSTEOLYSIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. TIBIAL INSERT (FAILURE MODE: PROSTHESIS WEAR): THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022 PRODUCT: 204-23-13 - PS TIBIAL INSERTS SZ 3, 13MM SERIAL: (B)(6) 510K: K933610 UDI: (B)(4) PRODUCT CODE: JWH X-RAY: NO OPERATIVE NOTES: NO. *CONCOMITANT DEVICES: 1581733 - 200-04-33 - CEMENTED FINNED TIB. TRA SZ 3F/3T, 1589846 - 234-02-03 - OPTETRAK ASY, PS CEMENTED FEMORAL, SZ 3,. 1610250 - 200-02-35 - THREE PEG PATELLA 35MM, 1610695 - 200-02-35 - THREE PEG PATELLA 35MM, 1620346 - 200-04-33 - CEMENTED FINNED TIB. TRA SZ 3F/3T, 1621701 - 234-03-03 - OPTETRAK ASY, PS CEMENTED FEMORAL, SZ 3. *IT IS NOT EVIDENT WHICH COMPONENTS ARE ASSOCIATED WITH THE LEFT OR RIGHT BILATERAL TKA. COMPONENTS AND CONCOMITANTS ARE ALL ACCOUNTED FOR BETWEEN THIS AND THE RELATED CASE/REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979020 OPTETRAK KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H