BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM PF CUP 50MM O.D. X 44 MM I.D.

    MDR report key: 1953089 · Received January 7, 2011

    Report

    Report Number
    1825034-2011-00003
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 1, 2009
    Report Date
    December 9, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, OR EXCESSIVE ACTIVITY". THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6), 2010. TO DATE, A RESPONSE HAS NOT BEEN RECEIVED FROM THE USER FACILITY. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA. THIS REPORT SUBMITTED (B)(6), 2011.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT SHE UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6), 2007. SUBSEQUENTLY, PATIENT RETURNED TO THE SURGEON COMPLAINING OF PAIN AND RADIOGRAPHS SHOWED THAT THE ACETABULAR CUP WAS LOOSE AND HAD SHIFTED. THE PATIENT WAS REVISED ON (B)(6), 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MAGNUM PF CUP 50MM O.D. X 44 MM I.D. PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 545950

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R