BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50MM TPR INSRT-3

    MDR report key: 7132628 · Received December 19, 2017

    Report

    Report Number
    0001825034-2017-11297
    Event Type
    Injury
    Date Received
    December 19, 2017
    Date of Event
    March 16, 2015
    Report Date
    December 19, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    P042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING SUBMITTED TO RELAY ON INITIAL INFORMATION AND INVESTIGATION RESULTS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-02006 MEDICAL DEVICES: M2A-MAGNUM PF CUP 52ODX46ID CATALOG#: US157852 LOT: 867630, M2A-MAGNUM MOD HD SZ 46MM CATALOG#: 157446 LOT#: 178590, BI-METRIC/X POR NC 9X125 CATALOG#: X180309 LOT#: 166270. REPORTED EVENT WAS CONFIRMED THROUGH REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY 5 YEAR POST-IMPLANTATION DUE TO PAIN, LACK OF MOBILITY, AND ELEVATED METAL ION LEVELS. DURING THE REVISION, SOME CORROSION WAS FOUND AT THE BASE OF THE HEAD. THERE WAS ALSO SIGNIFICANT CORROSION ON THE TRUNNION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911078 M2A-MAGNUM 42-50MM TPR INSRT-3 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 601660

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R