BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLORY/HEAD PRIMARY HIP SYSTEM

    MDR report key: 25250580 · Received May 21, 2026

    Report

    Report Number
    0001825034-2026-01442
    Event Type
    Injury
    Date Received
    May 21, 2026
    Report Date
    May 21, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K000538
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# US157854, LOT# 163700, M2A-MAGNUM PF CUP 54ODX48ID. CAT# 157448, LOT# 712230, M2A-MAGNUM MOD HD SZ 48MM. CAT# 139254, LOT# 379720, M2A-MAGNUM 42-50MM TPR INSRT-3. G2: FOREIGN ¿ EVENT OCCURRED IN CANADA. 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 THREE AND A HALF YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A LEFT HIP REVISION DUE TO PERSISTENT THIGH PAIN. THERE WAS A LOOSE FEMORAL STEM AND SUBSIDENCE. THERE WAS IMPINGEMENT OF THE STEM ON THE GREATER TROCHANTER. THE COMPONENT WAS NOTED AS UNDERSIZED DURING THE REVISION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480905 MALLORY/HEAD PRIMARY HIP SYSTEM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 813920

    Patients

    Seq Age Sex Outcome Treatment
    1