BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCED PATELLA 29M 3 PEG IMPLANT

    MDR report key: 20403670 · Received October 8, 2024

    Report

    Report Number
    1038671-2024-03880
    Event Type
    Injury
    Date Received
    October 8, 2024
    Date of Event
    September 25, 2024
    Report Date
    March 20, 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

    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 #1038671-2024-01369

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION. (D10) CONCOMITANT DEVICE(S): 02-022-35-2509 - TRULIANT TIB IMP PS INSERT SZ 2.5 9MM (B)(6). 02-022-45-2525 - TRULIANT TIB FIT TRAY CEM SZ 2.5F / 2.5T (B)(6). 02-020-11-0225 - TRULIANT PS CEM FEM PS CEM LEFT SZ 2.5 (B)(6).

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 4 YEARS AND 3 MONTHS POST THE INITIAL LEFT TKA, THE PATIENT COMPLAINED OF PAIN AND WAS REVISED DUE TO A RECALLED PATELLA. THE PATIENT WAS REVISED TO COMPETITOR DEVICES. 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
    21154 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 58 YR Female Required Intervention SEE H11.