BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MMX68 MM CUP

    MDR report key: 3241413 · Received July 22, 2013

    Report

    Report Number
    0001825034-2013-02808
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    November 2, 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. 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."

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THIS IS A DUPLICATE COMPLAINT, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. PLEASE REFERENCE MEDWATCH NUMBER 1825034-2013-01379.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT TOTAL HIP ARTHROPLASTY (B)(6), 2003. SUBSEQUENTLY, PATIENT WAS REVISED (B)(6) 2005 DUE TO LOOSENING OF THE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340604 M2A 38MMX68 MM CUP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 107270

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R