BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50M TPR INSRT +3

    MDR report key: 11561001 · Received March 24, 2021

    Report

    Report Number
    0001825034-2021-00848
    Event Type
    Injury
    Date Received
    March 24, 2021
    Date of Event
    November 28, 2016
    Report Date
    March 22, 2021
    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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 139258 M2A-MAGNUM 42-50M TPR INSRT +3 146420, 157448 M2A-MAGNUM MOD HD SZ 48MM 872140, US157854 M2A-MAGNUM PF CUP 54ODX48ID 205570, X180311 BI-METRIC/X POR NC 11X135 031770. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-02115, 0001825034-2017-02116, 0001825034 -2021 -00795.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY PERFORMED. THE PATIENT WAS REVISED APPROXIMATELY EIGHT YEARS LATER DUE TO PAIN. DURING THE REVISION, ACETABULAR OSTEOLYSIS, METALLOSIS, AND REACTIVE SYNOVITIS WAS NOTED. IT WAS ALSO NOTED THAT THERE WAS MINIMAL BONY ON GROWTH AROUND THE ACETABULAR SHELL. CORROSION WAS DISCOVERED DURING INVESTIGATION OF THE RETURNED HEAD. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462497 M2A-MAGNUM 42-50M TPR INSRT +3 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 146420

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R