BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTER-OP ACETABULAR SHELL

    MDR report key: 334886 · Received May 21, 2001

    Report

    Report Number
    MW1022006
    Event Type
    Injury
    Date Received
    May 21, 2001
    Date of Event
    May 11, 2001
    Report Date
    May 21, 2001
    Manufacturer
    SULZER ORTHOPEDICS, INC.
    Product Code
    KWB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED A SULZER ORTHOPEDICS, INC, INTER-OP ACETABULAR SHELL IMPLANT. THE DEVICE WAS EXPLANTED AT THIS FACILITY. PREOPERATIVE DIAGNOSIS: FAILED SULZER ACETABULUM, LEFT TOTAL HIP. POSTOPERATIVE DIAGNOSIS: SAME. PROCEDURE: REVISION ACETABULUM, LEFT TOTAL HIP. FOLLOWING THE ORIGINAL IMPLANT, PT HAD PROGRESSIVE INCREASING PAIN IN HIP WITH START UP PAIN, PAIN IN THE GROIN, AND DIFFICULTY WALKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23833 INTER-OP ACETABULAR SHELL HEMIS POR SHELL W/ SEALED SCREWHOLES SZ55MM KWB SULZER ORTHOPEDICS, INC. * 1435764

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention