BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC COMPLETE

    MDR report key: 24298584 · Received February 9, 2026

    Report

    Report Number
    0001825034-2026-00312
    Event Type
    Injury
    Date Received
    February 9, 2026
    Date of Event
    February 3, 2026
    Report Date
    May 13, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00880304514266
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN ¿ EVENT OCCURRED IN AUSTRALIA. G4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO 510(K) CAN BE DETERMINED. THE DEVICE IS CONSIDERED SIMILAR TO PRODUCT #51-107170 AND 510(K) K110400. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) - STEM. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY TWO YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO INSTABILITY, LOOSENING, AND A POSSIBLE METAL ALLERGY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488969 TAPERLOC COMPLETE PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. 7400207 00880304514266

    Patients

    Seq Age Sex Outcome Treatment
    1