BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 54MM O.D. X 48MM I.D.

    MDR report key: 6796350 · Received August 15, 2017

    Report

    Report Number
    0001825034-2017-06374
    Event Type
    Injury
    Date Received
    August 15, 2017
    Date of Event
    October 26, 2015
    Report Date
    August 15, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CONCOMITANT MEDICAL PRODUCTS - TAPERLOC STEM CATALOG#: 15-103206 LOT#: 871490, M2A MAGNUM TAPER ADAPTER CATALOG#: 139256 LOT#: 466890, HEAD CATALOG#:157448 LOT#:884830. REPORTED EVENT WAS CONFIRMED THROUGH REVIEW OF MEDICAL RECORDS. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND ASSOCIATED RISKS ARE ADDRESSED IN RISK DOCUMENTATION. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS:0001825034 - 2016 - 04002.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT RIGHT HIP REVISION APPROXIMATELY SIX YEARS POST-IMPLANTATION DUE TO UNKNOWN REASONS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. IT WAS REPORTED IN MEDICAL RECORDS RECEIVED THAT PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY 6 YEARS POST-IMPLANTATION DUE TO A FAILED IMPLANT. DURING THE PROCEDURE, THE PATIENT UNDERWENT AN ABDUCTOR REPAIR. THE FEMORAL HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED. PATIENT IS EXPERIENCING ONGOING PAIN WITH NERVE DAMAGE RELATED TO THE REVISION PROCEDURE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574151 M2A-MAGNUM PF CUP 54MM O.D. X 48MM I.D. PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 499280

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R