BEUDAMED
    FDA Adverse Event Injury Summary report: N

    J&J ACETABULAR POLYETHYLENE LINER

    MDR report key: 278672 · Received May 19, 2000

    Report

    Report Number
    278672
    Event Type
    Injury
    Date Received
    May 19, 2000
    Date of Event
    April 18, 2000
    Report Date
    April 21, 2000
    Manufacturer
    DEPUY INC. (J & J CO)
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A TOTAL HIP ARTHROPLASTY IN 1992 USING J&J COMPONENTS. PT WAS DOING WELL UNTIL APPROXIMATELY 1 MONTH AGO WHEN PT DEVELOPED SEVERE PAIN IN THE BUTTOCK. PT WAS SEEN BY A DOCTOR AND X-RAYS OBTAINED REVEALED EVIDENCE OF PROBABLE FRACTURE OF THE ACETABULAR DEFECT NOTED AROUND ONE OF THE SCREWS AS WELL AS OSTEOLYSIS OF THE PROXIMAL FEMUR. PT WAS ADMITTED ON 4/18/00 AND TAKEN TO SURGERY THAT SAME DAY. PT UNDERWENT A REVISION OF ACETABULAR COMPONENT WITH EXCHANGE OF LINER AND BONE GRAFTING OF OSTEOLYSIS OF THE LEFT ACETABULUM & LEFT PROXIMAL FEMUR. THE ACETABULAR LINER WAS FOUND TO BE DISPLACED AND BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J&J ACETABULAR POLYETHYLENE LINER POLYETHYLENE LINER (ACETABULAR) JDI DEPUY INC. (J & J CO) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| O