BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 56MM

    MDR report key: 25033129 · Received April 29, 2026

    Report

    Report Number
    0001825034-2026-01136
    Event Type
    Injury
    Date Received
    April 29, 2026
    Date of Event
    August 8, 2019
    Report Date
    April 28, 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# 139268 LOT# 832340 M2A-MAGNUM 52-60MM TPR INS 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 THE PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 9 YEARS AND 7 MONTHS POST-IMPLANTATION DUE TO LOOSENING OF THE FEMORAL STEM AND METAL RELATED PATHOLOGY. IT WAS NOTED FEMORAL LOOSENING WITH SUBSIDENCE DUE TO LACK OF OSTEOINTEGRATION, LEG SHORTENING, PSEUDOARTHROSIS, SYNOVITIS, SCLEROTIC FEMORAL BONE, AND A PSEUDO MEMBRANE WAS SENT TO PATHOLOGY FOR EVALUATION. ALL PRODUCTS WERE REVISED WITHOUT COMPLICATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418361 M2A-MAGNUM MOD HD SZ 56MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 199720

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H11 NARRATIVE