BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 48MM

    MDR report key: 23871368 · Received December 22, 2025

    Report

    Report Number
    0001825034-2025-04157
    Event Type
    Injury
    Date Received
    December 22, 2025
    Report Date
    April 23, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K101336
    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 54ODX48ID, ITEM: US157854, LOT: 951860, TAPERLOC POR FMRL 11X142, ITEM: 103205, LOT: 139730, M2A-MAGNUM 42-50M TPR INSRT +6 0/+6MMT1, ITEM: 139260, LOT: 810450. G2: FOREIGN ¿ CANADA. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) - HEAD. THE CUSTOMER INDICATED THAT THE PRODUCT 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 PRESENTED WITH HIGH METAL ION LEVELS. NO REVISION HAS BEEN REPORTED AT THIS TIME. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254901 M2A-MAGNUM MOD HD SZ 48MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 662010

    Patients

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