BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-38 CUP NON FLARED SZ 50MM

    MDR report key: 3241427 · Received July 22, 2013

    Report

    Report Number
    0001825034-2013-02807
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 14, 2005
    Report Date
    June 24, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    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, EXCESSIVE ACTIVITY." NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN."

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT TOTAL HIP ARTHROPLASTY (B)(6) 2004. SUBSEQUENTLY, PATIENT WAS REVISED (B)(6) 2005 DUE TO LOOSENING OF THE CUP AND FRACTURE OF THE MEDIAL ACETABULAR WALL. THE CUP WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340662 M2A-38 CUP NON FLARED SZ 50MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 450080

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R