BEUDAMED
    FDA Adverse Event Summary report: N

    ASR

    MDR report key: 2022393 · Received March 16, 2011

    Report

    Report Number
    2022393
    Date Received
    March 16, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 16, 2011
    Manufacturer
    DEPUY
    Product Code
    KWA
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    A RECALLED DEPUY HIP IMPLANT WAS REMOVED FROM THE PATIENT DURING REVISION TOTAL HIP ARTHROPLASTY. PREOPERATIVE DIAGNOSIS WAS A FAILED RIGHT HIP ARTHROPLASTY SECONDARY TO ACETABULAR COMPONENT LOOSENING. THE INITIAL IMPLANTATION SURGERY WAS 3-4 YEARS AGO. THE PATIENT SUFFERED A FALL IN THE EARLY POST-OPERATIVE PERIOD AFTER INITIAL SURGERY AND THE PATIENT DID WELL IN SPITE OF THAT. PATIENT HAD LEFT KNEE REPLACEMENT 1 YEAR AGO AND HAD AN INCIDENTAL X-RAY OF THEIR RIGHT HIP. THE X-RAY REVEALED LOOSENING OF THE ACETABULAR COMPONENT WHICH WAS FLIPPED. HER COMPONENT WAS A DEPUY ASR SHELL AND WAS FOUND TO HAVE SIGNIFICANTLY ELEVATED COBALT AND CHROMIUM ION LEVELS DESPITE BEING COMPLETELY ASYMPTOMATIC. SHE PRESENTED TO (B) (6) FOR REVISION OF HER ACETABULAR COMPONENT.======================MANUFACTURER RESPONSE FOR DEPUY ASR, FEMORAL AND ACETABULAR COMPONENT.======================MANUFACTURER REPRESENTATIVE WAS PRESENT FOR THE REVISION AND NOT AFFILIATED WITH THE IMPLANTED HOSPITAL. IT IS UNKNOWN WHETHER HE FILED A REPORT WITH DEPUY OR WHAT HIS PROTOCOL IS BUT HE WAS AWARE THAT THE EXPLANT WAS A RECALLED ITEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR PROSTHESIS, FEMORAL HEAD KWA DEPUY * *
    2 ASR PROSTHESIS, ACETABULAR COMPONENT KWA DEPUY ORTHOPAEDICS 999800750 2386867

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR