BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM PF CUP 48MM O.D. X 42MM I.D.

    MDR report key: 2210676 · Received August 12, 2011

    Report

    Report Number
    1825034-2011-00699
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    March 31, 2010
    Report Date
    July 15, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 ONE STATES, "MATERIAL SENSITIVITY REACTIONS". NUMBER FOURTEEN STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN". THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6), 2011. 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 IS MDR ONE OF FOUR (1825034-2011-00699 THROUGH 00702) FOR THIS EVENT. THIS REPORT SUBMITTED (B)(4), 2011.

    Description of Event or Problem · 1

    PATIENT REPORTED UNDERGOING TOTAL HIP ARTHROPLASTY ON (B)(6), 2009. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6), 2010, DUE TO HIP PAIN, CLICKING NOISES, AND METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MAGNUM PF CUP 48MM O.D. X 42MM I.D. PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 342500

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R