BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCED PATELLA 32MM 3 PEG IMPLANT

    MDR report key: 21552173 · Received March 7, 2025

    Report

    Report Number
    1038671-2025-01496
    Event Type
    Injury
    Date Received
    March 7, 2025
    Date of Event
    January 29, 2024
    Report Date
    March 7, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862314284
    PMA / PMN Number
    K160484
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: (B)(6) - 02-022-35-4015 - TRULIANT TIB IMP PS INSERT SZ 4 15MM. (B)(6) - 02-022-45-4040 - TRULIANT TIB FIT TRAY CEM SZ 4F / 4T. (B)(6) - 02-012-60-1425 - TRU STEM EXT 14MM X 25MM. (B)(6) - 02-020-11-0240 - TRULIANT PS CEM FEM PS CEM LEFT SZ 4. 499(B)(6)4770 - 204-70-00 - TIBIAL STEM EXT. SCREW. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2024-01315. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, INSTABILITY, AND PATELLAR LOOSENING AND FEMORAL LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. 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

    IT WAS REPORTED THAT APPROXIMATELY 75 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PREMATURE POLYETHYLENE WEAR FROM RECALLED POLYETHYLENE INSERT, ASEPTIC LOOSENING OF FEMORAL AND PATELLAR COMPONENTS. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863278 ADVANCED PATELLA 32MM 3 PEG IMPLANT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862314284

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention| H SEE H11.