BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 52MM

    MDR report key: 7370583 · Received March 26, 2018

    Report

    Report Number
    0001825034-2018-02065
    Event Type
    Injury
    Date Received
    March 26, 2018
    Date of Event
    August 15, 2017
    Report Date
    April 9, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK051569
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS ABLE TO BE CONFIRMED VIA OPERATIVE NOTES. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: US157858, M2A-MAGNUM PF CUP 58ODX52ID, 199080, 12-103209, TAPERLOC POR RED/DIST 17.5X155, 645740, 139266, M2A-MAGNUM 52-60MM TPR INSRT-3, 092710. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEFT HIP HAS BEEN REVISED TEN YEARS POST-IMPLANTATION DUE TO PAIN AND METALLOSIS. INFLAMMATORY DEBRIS AND TISSUE STAINING FROM METALLOSIS WERE FOUND. THE HEAD WAS REVISED TO AN ACTIVE ARTICULATION SYSTEM. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214023 M2A-MAGNUM MOD HD SZ 52MM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 762810

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R