BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASR 300

    MDR report key: 1904199 · Received November 14, 2010

    Report

    Report Number
    1904199
    Event Type
    Malfunction
    Date Received
    November 14, 2010
    Date of Event
    September 28, 2010
    Report Date
    November 14, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    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 PATIENT'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.PATIENT 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 HOW ABNORMAL AND DIFFERENT THE LEFT HIP WAS. SHE EVENTUALLY SOUGHT MEDICAL ADVICE, AT WHICH TIME SHE WAS RADIOGRAPHICALLY AND SEROLOGICALLY EVALUATED. THE MD FELT THAT THE POSITION OF HER LEFT ACETABULAR CUP MIGHT BE LESS THAN IDEAL AND MIGHT BE CONTRIBUTING TO WHAT APPEARED TO BE A BEARING SURFACE ISSUE AND INCREASED METAL LINES IN HER BLOOD. HER EXAM WAS CONSISTENT WITH PROSTHETIC IMPINGEMENT. MD'S HAVE RECOMMENDED SHE CONSIDER REVISION ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR 300 PROSTHESIS, HIP, SEMI-CONSTRAINED, CUP KWA DEPUY ORTHOPAEDICS, INC. 999830750 279894
    2 ASR PROSTHESIS, HIP, FEMORAL HEAD KWA DEPUY ORTHOPAEDICS, INC. 999890245 2863664

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR