BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC

    MDR report key: 24603724 · Received March 16, 2026

    Report

    Report Number
    0001825034-2026-00587
    Event Type
    Injury
    Date Received
    March 16, 2026
    Date of Event
    February 19, 2026
    Report Date
    March 16, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    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). D10: CAT# 00-5001-046-00 LOT# 64662152 BIPOLAR METAL SHELL 46 MM OD. CAT# 163661 LOT# J7444670 28MM DIA COCR MOD HD -3MM NK. CAT# 00-5001-448-28 LOT# 65970522 LINER ASSY 44/45/46 OD X 28ID. G2: FOREIGN ¿ EVENT OCCURRED IN AUSTRALIA. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) - STEM. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY SIX WEEKS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO TRAUMA AND FRACTURE. THE PATIENT FELL LEADING TO FEMUR FRACTURE AND LOOSENING OF THE STEM IMPLANT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663656 TAPERLOC PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. 7823457

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H