BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 46MM

    MDR report key: 25016880 · Received April 28, 2026

    Report

    Report Number
    0001825034-2026-01119
    Event Type
    Injury
    Date Received
    April 28, 2026
    Report Date
    April 28, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K113271
    Removal / Correction Number
    N/A
    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: M2A-MAGNUM PF CUP 52ODX46ID, ITEM: US157852, LOT: 117780. TAPERLOC POR LAT FMRL 6.0X132, ITEM: 11-103201, LOT: 232410. M2A-MAGNUM 42-50 TPR INSRT STD, ITEM: 139256, LOT: 464380. G2: FOREIGN: CANADA. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) - HEAD. THE CUSTOMER INDICATED THAT THE DEVICE REMAINS IMPLANTED; THEREFORE, IT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING METAL-RELATED PATHOLOGIES APPROXIMATELY SIXTEEN (16) YEARS POST-IMPLANTATION. NO MEDICAL INTERVENTION HAS BEEN REPORTED TO DATE. FOLLOW-UPS TO GATHER ADDITIONAL INFORMATION ARE CURRENTLY IN PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1073346 M2A-MAGNUM MOD HD SZ 46MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. 880780

    Patients

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