BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-38 CUP NON FLARED SZ 58MM

    MDR report key: 3250274 · Received July 26, 2013

    Report

    Report Number
    0001825034-2013-02937
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    December 28, 2006
    Report Date
    June 26, 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."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ENROLLED IN THE M2A 38 CLINICAL STUDY UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. A SUBSEQUENT REVISION WAS PERFORMED (B)(6) 2006 DUE TO ASEPTIC LOOSENING. THE CUP AND HEAD WERE REMOVED AND REPLACED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350831 M2A-38 CUP NON FLARED SZ 58MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 330880

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R