BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGNUM M2A RECAP CUP

    MDR report key: 24674419 · Received March 24, 2026

    Report

    Report Number
    0001825034-2026-00696
    Event Type
    Injury
    Date Received
    March 24, 2026
    Date of Event
    March 10, 2026
    Report Date
    March 24, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 7100100306 LOT# 2009120800 PPF LTZ STEM SZ 06X160MM. CAT# 130830 LOT# 1921728 MAGNUM TPR ADPR TI 42-50/0MM M12/14. G2: FOREIGN - EVENT OCCURRED IN ITALY. 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 APPROXIMATELY 16 YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO ARTICULAR PSEUDOTUMOR WITH METAL ON METAL PROSTHESIS AND STEM MOBILIZATION. THE PATIENT HAD UNEXPECTED WORSENING OF HEALTH CONDITION AND UNDERWENT A REVISION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738211 MAGNUM M2A RECAP CUP PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. 1944096

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H