BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 1942093 · Received December 17, 2010

    Report

    Report Number
    1818910-2010-10184
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    September 28, 2010
    Report Date
    November 19, 2010
    Manufacturer
    DEPUY INTL, LTD
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THERE WAS NO EVIDENCE OF SNAPPING, BUT THERE WAS A LARGE AMOUNT OF FLUID THAT COULD POSSIBLY BE CORRELATED WITH INFLAMMATION FROM METAL PARTICLES OF ACCELERATED WEAR. THE PT'S METAL SUPPRESSION CT SCAN WAS REVIEWED BY OUR JOINT SURGEONS AS WELL AS OUR ORTHOPAEDIC RADIOLOGIST. ALL PHYSICIANS DID FEEL AS THOUGH THE GRINDING, CATCHING, AND CLUNKING SENSATION SHE IS FEELING IN HER LEFT HIP IS A SIGNIFICANT PROBLEM. PT HAD LEFT HIP ARTHROPLASTY PERFORMED A SHORT TIME AGO. SHE HAD RATCHETING AND CATCHING ON THE LEFT HIP FROM EARLY ON POST OPERATIVELY. SHE THEN UNDERWENT RIGHT HIP ARTHROPLASTY AND IMMEDIATELY NOTICED LOW ABNORMAL AND DIFFERENT THE LEFT HIP WAS. SHE EVENTUALLY SOUGHT MEDICAL ADVICE, AT WHICH TIME SHE WAS RADIOGRAPHICALLY AND SEROLOGICALLY EVAL... DOI (B)(6) 2009 DOR (B)(6) 2010 (LEFT HIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 45 87 KWA KWA DEPUY INTL, LTD NA 2863664

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention