BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 46MM

    MDR report key: 23907319 · Received December 29, 2025

    Report

    Report Number
    0001825034-2025-04210
    Event Type
    Injury
    Date Received
    December 29, 2025
    Date of Event
    May 15, 2015
    Report Date
    April 16, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SUGGESTED COMPONENT CODE: MECHANICAL (G04) - HEAD. D10: CAT#: 15-103201, LOT#: 164250 TAPERLOC MICROP LAT FMRL 6.0MM. CAT#: 139256, LOT#: 062880 M2A-MAGNUM 42-50 TPR INSRT STD. 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 A PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH METAL IONS. NO FURTHER DETAILS OR OUTCOMES PROVIDED. IT WAS REPORTED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531330 M2A-MAGNUM MOD HD SZ 46MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. 638340

    Patients

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