BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM

    MDR report key: 25236553 · Received May 20, 2026

    Report

    Report Number
    0001825034-2026-01398
    Event Type
    Injury
    Date Received
    May 20, 2026
    Date of Event
    June 6, 2017
    Report Date
    May 20, 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# 139258, LOT# 861730, M2A-MAGNUM 42-50M TPR INSRT +3. CAT# 11-103206 LOT# 313410 TAPERLOC POR LAT FMRL 12.5X145. 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 SEVEN AND A HALF YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A LEFT HIP REVISION DUE TO A PSEUDOTUMOR WITH METAL ON METAL CONSTRUCT. THE STEM WAS RETAINED AND OTHER COMPONENTS REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37751 M2A MAGNUM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. 833560

    Patients

    Seq Age Sex Outcome Treatment
    1