BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 54MM

    MDR report key: 24997701 · Received April 27, 2026

    Report

    Report Number
    0001825034-2026-01075
    Event Type
    Injury
    Date Received
    April 27, 2026
    Report Date
    April 9, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K101336
    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). PROPOSED COMPONENT CODE: MECHANICAL (G04) - HEAD. D10: CAT# 11-103206, LOT# 840990 TAPERLOC POR LAT FMRL 12.5X145. CAT# 139264, LOT# 468160 M2A-MAGNUM 52-60MM TPR INSRT-6. G2: FOREIGN - EVENT OCCURRED IN CANADA. 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 THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. IT WAS REPORTED THAT THERE ARE ALLEGATIONS OF COMPLICATIONS WITH METAL WEAR. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161146 M2A-MAGNUM MOD HD SZ 54MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 946600

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other SEE H11 NARRATIVE.