BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEMENTED FINNED TIB. TRA SZ 2F/2T

    MDR report key: 21001481 · Received December 23, 2024

    Report

    Report Number
    1038671-2024-04985
    Event Type
    Injury
    Date Received
    December 23, 2024
    Date of Event
    January 24, 2023
    Report Date
    December 30, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K932776
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 200-02-32 - THREE PEG PATELLA 32MM (B)(6), 200-04-22 - CEMENTED FINNED TIB. TRA SZ 2F/2T (B)(6), 230-03-02 - OPTETRAK ASY, CR CEMENTED FEMORAL, SZ 2, 1519636. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2023-02610, 1038671-2024-04984. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, LOOSENING, AND INSTABILITY 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 APPROXIMATELY 117 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT, THE PATIENT UNDERWENT A REVISION SURGERY AFTER EXPERIENCING PROSTHESIS WEAR, CHRONIC PAIN, INSTABILITY AND LOOSENING. A REVISION OPERATIVE REPORT WAS PROVIDED. INTRAOPERATIVELY, IT WAS NOTED THAT INSTABILITY, LOOSENING AND DEBONDING WAS OBSERVED. FEMORAL AND TIBIAL COMPONENTS WERE EASILY REMOVED AND THE PATELLA COMPONENT HAD MILD TO MODERATE WEAR. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. THERE IS NO ADDITIONAL INFORMATION. LEGAL CASE USA PATIENT ID: (B)(6) AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2010. APPROXIMATELY 12 YEARS AND 9 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2023. 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. REVISION OP REPORT ON (B)(6) 2023 DIAGNOSIS: FAILED RIGHT KNEE THERE WAS INSTABILITY, LOOSENING AND DEBONDING. FEMORAL AND TIBIAL COMPONENTS WERE EASILY REMOVED. PATELLA COMPONENT HAD MILD TO MODERATE WEAR. PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE PACU IN STABLE CONDITION. EBI INITIAL SURGERY ATTACHED. HISTORICAL RECORD & SMARTSOLVE SEARCHED FOR SN/PATIENT NAME WITH NO RESULTS. OPERATIVE REPORT FROM REVISION SURGERY ATTACHED. ITEM NUMBER AND FULL DESCRIPTION SERIAL NUMBER (B)(6) - CR TIBIAL INSERT SZ 2, 9MM, SLOPE (B)(6) SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510(K): K932690. CONCOMITANTS: 200-02-32 - THREE PEG PATELLA 32MM (B)(6), 200-04-22 - CEMENTED FINNED TIB. TRA SZ 2F/2T (B)(6), 230-03-02 - OPTETRAK ASY, CR CEMENTED FEMORAL, SZ 2, 1519636.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2626123 CEMENTED FINNED TIB. TRA SZ 2F/2T PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Hospitalization| R SEE H11