BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY FM ACET SHL 52 OD UNIV

    MDR report key: 24630267 · Received March 18, 2026

    Report

    Report Number
    0001822565-2026-00838
    Event Type
    Injury
    Date Received
    March 18, 2026
    Report Date
    March 18, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K934765
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) D10: FEMORAL HEAD +3.5X28MM DIA ITEM: 00801802803 LOT: UNKNOWN. XLPE 10D POLYLINER 50/52/54X28 ITEM: 00631005028 LOT: 6193043. G2: FOREIGN ¿ SPAIN THE CUSTOMER INDICATED THAT THE PRODUCT REMAINS IMPLANTED; THEREFORE, IT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A RIGHT HIP REVISION APPROXIMATELY 16 YEARS POST-IMPLANTATION DUE TO PAIN. THE PATIENT WAS NOTED TO HAVE AGE-RELATED BONE DETERIORATION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685866 TRILOGY FM ACET SHL 52 OD UNIV PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 61486663

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SEE H11