BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ORTHOPAEDICS, INC

    MDR report key: 1353107 · Received March 27, 2009

    Report

    Report Number
    MW5010511
    Event Type
    Injury
    Date Received
    March 27, 2009
    Date of Event
    June 5, 2006
    Report Date
    March 25, 2009
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RIGHT TOTAL HIP ARTHROPLASTY DONE IN 2006 ON A FEMALE WITH DEPUY PRODIGY STEM SM. STATURE SIZE 10.5. DOING WELL IN 2008 NO PAIN AND APPROX THREE MONTHS LATER, AFTER LEFT THA. NEW SPONTANEOUS ONSET OF RIGHT HIP PAIN THREE MONTHS PRIOR. PAIN PROGRESSED XRAY SHOWED WELL FIXED BROKEN STEM THE DAY BEFORE. IN RETROSPECT XRAY THE NEXT DAY, SHOWED A CRACK IN THE STEM. I HAVE XRAYS AND A BONE SCAN THAT SUGGEST THE IMPLANT WAS WELL FIXED, CORRECTLY IMPLANTED AND APPROPRIATELY SIZED. THE PT IS LOW DEMAND AND DID NOT HAVE A HISTORY OF TRAUMA. THIS IS THE SECOND DEPUY SIZE 105 THAT I HAVE HAD BREAK WHEN WELL FIXED AT ABOUT 2-3 YEARS AFTER IMPLANTATION IN A PT. I THINK THEY HAD TO PUT A WEIGHT LIMIT ON THIS SIZE STEM. MANUFACTURE IT DIFFERENTLY OR MAKE IT IN SIZE 11.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ORTHOPAEDICS, INC DEPUY PRODIGY 10.5 SMALL KWY DEPUY ORTHOPAEDICS, INC. PRODIGY AR2AA1000

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention