BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-38 CUP 50MM

    MDR report key: 6459725 · Received April 5, 2017

    Report

    Report Number
    0001825034-2017-02258
    Event Type
    Injury
    Date Received
    April 5, 2017
    Date of Event
    March 7, 2017
    Report Date
    April 21, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. 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:0001825034-2017-02258 & 0001825034-2017-02259.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: M2A FEMORAL HEAD, CATALOG#: 11-173662, LOT#: 231930; INTEGRAL FEMORAL STEM, CATALOG#: 11-166011, LOT#: 531841. IT HAS BEEN INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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 CONTRIBUTE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED THIRTEEN YEARS POST-IMPLANTATION DUE TO PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242606 M2A-38 CUP 50MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 163970

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R