BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLORY/HEAD PRIMARY HIP SYSTEM

    MDR report key: 25250598 · Received May 21, 2026

    Report

    Report Number
    0001825034-2026-01443
    Event Type
    Injury
    Date Received
    May 21, 2026
    Date of Event
    September 22, 2017
    Report Date
    May 21, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MEH
    PMA / PMN Number
    K021403
    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# 163662 LOT# 494520 28MM MOD HD STD NECK TP1 TAPER. CAT# EP-200154 LOT# 115890 ACT ARTIC E1 HIP BRG 28X48MM. 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 YEARS POST-REVISION, THE PATIENT UNDERWENT A LEFT HIP REVISION DUE TO A LOOSE STEM. DURING THE REVISION, THERE WAS NO SIGN OF INFECTION BUT CULTURES WERE POSITIVE FOR STAPHYLOCOCCUS LUGDUNENSIS. ALL COMPONENTS REMOVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364367 MALLORY/HEAD PRIMARY HIP SYSTEM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS MEH ZIMMER BIOMET, INC. 341830

    Patients

    Seq Age Sex Outcome Treatment
    1