BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CC TIBIAL INSERT SZ 3, 13MM

    MDR report key: 16876222 · Received May 5, 2023

    Report

    Report Number
    1038671-2023-00911
    Event Type
    Injury
    Date Received
    May 5, 2023
    Date of Event
    December 16, 2022
    Report Date
    January 3, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862054265
    PMA / PMN Number
    K954208
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 2031088, 200-02-35 - THREE PEG PATELLA 35MM. 1692843, 204-04-34 - TRAPEZOID TIBIAL TRAY SZ 3F/4T. 2042025, 204-34-04 - FLUTED STEM EXTENSION 40L X 14 MM. 8504716, 210-01-03 - NMC FEMORAL SZ 3. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    RECALL NUMBER: Z-0019-2022. 1038671-2025-00060, 1038671-2025-00059, 1038671-2025-00057 THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0019-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2025-00060, 1038671-2025-00059, AND 1038671-2025-00057. D10: CONCOMITANTS: 2031088 200-02-35 - THREE PEG PATELLA 35 MM; 1692843 204-04-34 - TRAPEZOID TIBIAL TRAY SZ 3F/4T; 2042025 204-34-04 - FLUTED STEM EXTENSION 40L X 14 MM; 8504716 210-01-03 - NMC FEMORAL SZ 3. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, TIBIAL LOOSENING, AND FEMORAL LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. 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 AND RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION A FEMALE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2011. APPROXIMATELY 11 YEARS AND 7 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION DUE TO PROSTHESIS WEAR. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. OP REPORT (B)(6) 2023/ K MCGUINNESS RECEIVED VIA LEGAL (B)(6) 2023. POSTOPERATIVE DIAGNOSIS: FAILED RIGHT KNEE DUE TO POLYETHYLENE WEAR. FINDINGS: PARTIAL LOOSE FEMORAL AND TIBIAL COMPONENTS WITH MILD TO MODERATE AMOUNT OF OSTEOLYSIS BEHIND THE FEMORAL COMPONENT AND AROUND THE TIBIAL COMPONENT. THE PATELLAR COMPONENT WAS WELL FIXED BUT ALSO HAD A MODERATE AMOUNT OF POLYETHYLENE WEAR. AN ACE WRAP FROM TOE TO THIGH WAS APPLIED. THE PATIENT WAS AWAKENED AND TRANSFERRED TO RECOVERY IN STABLE CONDITIONS WITH NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1691493 CC TIBIAL INSERT SZ 3, 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. CC TIBIAL INSERT SZ 3, 13MM UNK 10885862054265

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Hospitalization| R SEE H10| SEE H11