BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 52ODX46ID

    MDR report key: 9611295 · Received January 21, 2020

    Report

    Report Number
    0001825034-2020-00322
    Event Type
    Injury
    Date Received
    January 21, 2020
    Date of Event
    May 13, 2019
    Report Date
    January 20, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    K101336
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET TAPER INSERT CAT#139254 LOT#844730, BIOMET HEAD CAT#157446 LOT#843560, BIOMET CUP CAT#US157852 LOT#151290, BIOMET STEM CAT#11-103204 LOT#939100. REPORTED EVENT WAS CONFIRMED WITH MEDICAL RECORDS PROVIDED. REVIEW OF THE REVISION OPERATIVE NOTES CONFIRMS THAT THE PATIENT HAD RIGHT REVISION DUE TO PAIN AND ELEVATED METAL IONS. OPERATIVE NOTES STATES MODERATE SEROUS FLUID, NO PURULENT FLUID. NO CORROSION. NO WEAR OR LOOSE BODIES IN SOCKET. SCAR TISSUE EXCISED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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. THIS DEVICE REMAINS IMPLANTED IN THE PATIENT. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 04741.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS UNDERWENT AN INITIAL RIGHT HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 10 YEARS LATER DUE TO METALLOSIS. IT WAS NOTED THE BLOOD SERUM COBALT AND CHROMIUM LEVELS WERE ELEVATED. DURING REVISION NON PURULENT SEROUS FLUID AND DISCOLORED TISSUE WAS NOTED IN THE HIP SPACE. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73783 M2A-MAGNUM PF CUP 52ODX46ID PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. N/A 151290

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R