BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 44MM

    MDR report key: 25051934 · Received April 30, 2026

    Report

    Report Number
    0001825034-2026-01173
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    May 11, 2022
    Report Date
    April 30, 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). D10: BIOMET PART NUMBER 11-104108 MLRY-HD POR FMRL 8X145MM LOT NUMBER 128190. BIOMET PART NUMBER 139252 M2A-MAGNUM 42-50MM TPR INSRT-6 LOT NUMBER 902500. G2: FOREIGN - EVENT OCCURRED IN CANADA. H6: PROPOSED COMPONENT CODE : MECHANICAL (G04) - HEAD. 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 WITH HIP DYSPLASIA UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, PATIENT DEVELOPED PAIN AND UNDERWENT A REVISION APPROXIMATELY 15 YEARS POST-IMPLANTATION. DURING THE PROCEDURE, ENCOUNTERED TROCHANTERIC BURSITIS, BEAD DISASSOCIATION FROM THE CUP WITH CUP DISLODGEMENT AND EROSION THROUGH THE ANTERIOR COLUMN, METAL STAINED TISSUES, AND A PSEUDO CAPSULE. THE CUP, HEAD, AND TAPER WERE ALL 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
    62298 M2A-MAGNUM MOD HD SZ 44MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 871730

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown Hospitalization| R