BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCED PATELLA 29M 3 PEG IMPLANT

    MDR report key: 19946022 · Received August 8, 2024

    Report

    Report Number
    1038671-2024-02753
    Event Type
    Injury
    Date Received
    August 8, 2024
    Date of Event
    July 22, 2024
    Report Date
    March 27, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862314277
    PMA / PMN Number
    K160484
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: (B)(6) 02-010-06-0240 - TRU CC FEMORAL SIZE 4 LEFT. (B)(6) 02-010-06-0541 - TRU POST. AUG. SIZE 4, 5MM. (B)(6) 02-010-06-0541 - TRU POST. AUG. SIZE 4, 5MM. (B)(6) 02-012-45-4030 - LGC TIBIAL FIT TRAY CEM SZ 4F / 3T. (B)(6) 02-012-60-1440 - TRU STEM EXT 14MM X 40MM. (B)(6) 02-012-60-1440 - TRU STEM EXT 14MM X 40MM. (B)(6) 204-70-00 - TIBIAL STEM EXT. SCREW. (B)(6) 208-05-04 - CC DISTAL FEM AUGMENT SZ 4, 5MM. (B)(6) 208-05-04 - CC DISTAL FEM AUGMENT SZ 4, 5MM.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION: PLEASE DISREGARD THIS REPORT AS IT WAS SUBMITTED IN ERROR. EVENT WAS PREVIOUSLY REPORTED UNDER REPORT # 1038671-2024-03038.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 3 YEARS AND 10 MONTHS POST THE PREVIOUS LEFT REVISION, THE PATIENT WAS REVISED AGAIN BECAUSE THE PATELLA FELL OUT AND HAD TO BE BONE GRAFTED DUE TO OSTEOLYSIS OF THE PATELLA. THE PATIENT WILL REQUIRE AN ADDITIONAL SURGERY TO REPAIR THE PATELLA ONCE THE BONE GRAFT HAS GROWN NEW BONE. 30CC OF BONE GRAFT WAS USED TO GRAFT THE PATIENT'S PATELLA. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1661330 ADVANCED PATELLA 29M 3 PEG IMPLANT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862314277

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention SEE H11