BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREW

    MDR report key: 24628261 · Received March 18, 2026

    Report

    Report Number
    0001822565-2026-00842
    Event Type
    Injury
    Date Received
    March 18, 2026
    Report Date
    March 18, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    NA
    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: TRILOGY FM ACET SHL 52 OD UNIV. ITEM: 00620005220. LOT: 61486663. FEMORAL HEAD +3.5X28MM DIA. ITEM: 00801802803. LOT: UNKNOWN. XLPE 10D POLYLINER 50/52/54X28. ITEM: 00631005028. LOT: 6193043. UNKNOWN STEM. ITEM: UNKNOWN. LOT: UNKNOWN. UNKNOWN SCREW. UNKNOWN SCREW. 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
    685792 UNKNOWN SCREW PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SEE H11.