BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM

    MDR report key: 25250693 · Received May 21, 2026

    Report

    Report Number
    0001825034-2026-01448
    Event Type
    Injury
    Date Received
    May 21, 2026
    Report Date
    May 21, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    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#: 139252, LOT#: 356370 M2A-MAGNUM 42-50MM TPR INSRT-6. CAT#: 11-104114, LOT#: 134010 MLRY-HD POR FMRL 14X175MM. G2: FOREIGN ¿ EVENT OCCURRED IN CANADA. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) - HEAD. 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 ELEVEN YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A RIGHT HIP REVISION DUE TO PAIN, HIGH METAL IONS, BURSITIS, AND USING A CANE. DURING THE REVISION VERY LITTLE METAL STAINING WAS NOTED, THE FEMORAL STEM WAS WELL FIXED. THE SHELL WAS LOOSE, RETROVERTED, AND ORIENTED POSTERIORLY; AFTER REMOVAL, PSEUDOMEMBRANOUS TISSUE AND ANTERIOR WALL BONE LOSS WAS NOTED. STEM WAS RETAINED, WHILE ALL OTHER COMPONENTS WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347935 M2A MAGNUM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. 555720

    Patients

    Seq Age Sex Outcome Treatment
    1