BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HEAD 46MM O.D.

    MDR report key: 2120546 · Received June 10, 2011

    Report

    Report Number
    1825034-2011-00494
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    April 6, 2011
    Report Date
    May 17, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER INFORMATION NEEDED TO REVIEW DEVICE HISTORY RECORDS WAS UNAVAILABLE. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER FOURTEEN STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN". THE MODULAR HEAD AND TAPER ADAPTER WERE STILL ASSEMBLED AND NO ATTEMPT WAS MADE TO SEPARATE THESE COMPONENTS. THE MODULAR HEAD APPEARS TO SHOW EVIDENCE OF SUBLUXATION OF THE JOINT AND SCRATCHING OF THE BEARING SURFACES. BASED UPON THE APPEARANCE OF THE PARTS, WEAR RATES DID NOT APPEAR TO BE EXCESSIVE. 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 REPORT SUBMITTED (B)(6), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6), 2011, DUE TO PAIN. THE MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MAGNUM MODULAR HEAD 46MM O.D. PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R