BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM ONE-PIECE CUP 38MM X 52 O.D.

    MDR report key: 2073068 · Received April 29, 2011

    Report

    Report Number
    1825034-2011-00313
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    March 25, 2010
    Report Date
    April 1, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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: "IT HAS BEEN REPORTED THAT WEAR DEBRIS MAY INITIATE A CELLULAR RESPONSE RESULTING IN OSTEOLYSIS OR OSTEOLYSIS MAY BE A RESULT OF LOOSENING OF THE IMPLANT." DATE IMPLANTED - 2006; EXACT DATE UNKNOWN. THIS REPORT FILED APRIL 29, 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY IN 2006. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)96) 2010 DUE TO PAIN AND ACETABULAR OSTEOLYSIS. THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A 38MM ONE-PIECE CUP 38MM X 52 O.D. PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 164000

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R