BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTER-OP ACETABULAR SHELL

    MDR report key: 322163 · Received March 20, 2001

    Report

    Report Number
    MW1021431
    Event Type
    Injury
    Date Received
    March 20, 2001
    Date of Event
    March 13, 2001
    Report Date
    March 20, 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 MEDICA, SULZER ORTHOPEDICS, INC, INTER-OP ACETABULAR SHELL IMPLANT. THE IMPLANT WAS EXPLANTED. PT'S OPERATIVE FINDINGS INDICATED THAT THE ACETABULAR COMPONENT HAD NO EVIDENCE OF BONY INGROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12326 INTER-OP ACETABULAR SHELL HEMIS-POROUS SHELL W/ SEALED SCREWHOLES KWB SULZER ORTHOPEDICS, INC. * 1420464

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention