BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 48MM

    MDR report key: 23862381 · Received December 22, 2025

    Report

    Report Number
    0001825034-2025-04100
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    May 25, 2017
    Report Date
    May 1, 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). SUGGESTED COMPONENT CODE: MECHANICAL (G04) - HEAD. D10: CAT#: X180310, LOT#: 676580 BI-METRIC/X POR NC 10X130. 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 THAT A PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 9 YEARS LATER DUE TO PAINFUL METAL-ON-METAL. DURING THE REVISION SLIGHT WEAR WAS NOTED ON THE TRUNNION AND CAPSULE FRAGMENTS WERE REMOVED FROM THE ACETABULUM. THE STEM WAS RETAINED ALL OTHER COMPONENTS WERE REVISED WITHOUT COMPLICATIONS. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238469 M2A-MAGNUM MOD HD SZ 48MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH ZIMMER BIOMET, INC. 170340

    Patients

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