BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTER-OP ACETABULAR SHELL

    MDR report key: 355261 · Received October 5, 2001

    Report

    Report Number
    MW1023033
    Event Type
    Injury
    Date Received
    October 5, 2001
    Date of Event
    August 30, 2001
    Report Date
    October 5, 2001
    Manufacturer
    SULZER ORTHOPEDICS, INC.
    Product Code
    LPH
    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 PROSTHESIS WAS EXPLANTED. PREOPERATIVE DIAGNOSIS: WAS EXPLANTED. PREOPERATIVE DIAGNOSIS: PAINFUL RIGHT HIP, STATUS POST TOTAL HIP REPLACEMENT. POSTOPERATIVE DIAGNOSIS: PAINFUL RIGHT HIP, STATUS POST TOTAL HIP REPLACEMENT WITH NO EVIDENCE OF ACETABULAR LOOSENING. PROCEDURE: EXPLORATION OF RIGHT HIP WITH EXCHANGE OF ACETABULAR INSERT AND FEMORAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44942 INTER-OP ACETABULAR SHELL HEMIS POR SHELL W/ SEALED SCREWHOLES LPH SULZER ORTHOPEDICS, INC. * 1367690

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention