BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 52ODX46ID

    MDR report key: 8063549 · Received November 13, 2018

    Report

    Report Number
    0001825034-2018-10607
    Event Type
    Injury
    Date Received
    November 13, 2018
    Date of Event
    January 30, 2018
    Report Date
    July 17, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE REVISION OPERATIVE NOTES RECORDS IDENTIFIED THAT THE PATIENT WAS REVISED DUE TO FAILED MOM CONSTRUCT. IT NOTED EVIDENCE OF SIGNIFICANT SYNOVITIS AND METAL ON METAL WEAR. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 157446 ¿ M2A MAGNUM HEAD ¿ 953610, 11-103202 ¿ TAPERLOC FEMORAL STEM 0 604780, 139254 ¿ M2A MANGUM TAPER ¿ 292980. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 10 YEARS POST IMPLANTATION DUE TO SYNOVITIS AND METAL ON METAL WEAR. THE HEAD AND CUP COMPONENTS WERE REMOVED AND REPLACED.

    Additional Manufacturer Narrative · 1

    (B)(4). UNKNOWN SHELL ¿ UNKNOWN PART AND LOT. UNKNOWN STEM ¿ UNKNOWN PART AND LOT. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 10604. 0001825034 - 2018 - 10609.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A HIP REVISION AT AN UNKNOWN AMOUNT OF TIME POST IMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903808 M2A-MAGNUM PF CUP 52ODX46ID PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 797490

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R . | .