BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM FLARED ONE PIECE CUP 38MM ID X 56MM OD

    MDR report key: 2110189 · Received June 1, 2011

    Report

    Report Number
    1825034-2011-00458
    Event Type
    Injury
    Date Received
    June 1, 2011
    Report Date
    May 5, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION PERTAINING TO PATIENT FOLLOW-UP VISITS, LABORATORY RESULTS AND DETAILS ON WHETHER OR NOT A REVISION PROCEDURE HAS OCCURRED HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA WITH DETAILS. THIS REPORT FILED (B)(6), 2011.

    Description of Event or Problem · 1

    PATIENT REPORTED TO HAVE UNDERWENT TOTAL HIP ARTHROPLASTY PROCEDURE ON (B)(6), 2007 AND ALLEGES THAT SUBSEQUENT COMPLICATIONS HAVE OCCURRED. THE PATIENT REPORTS ATROPHY, NERVE DAMAGE, CHRONIC PAIN AND RECENT UNUSUAL LABORATORY RESULTS. THERE IS NO INDICATION OF A REVISION PROCEDURE AND NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A 38MM FLARED ONE PIECE CUP 38MM ID X 56MM OD PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 833660

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R