BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SULZER MEDICA

    MDR report key: 316778 · Received February 19, 2001

    Report

    Report Number
    316778
    Event Type
    Injury
    Date Received
    February 19, 2001
    Date of Event
    February 1, 2001
    Report Date
    February 13, 2001
    Manufacturer
    SULZER MEDICA
    Product Code
    KWB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HIP JOINT REVISION-THE SULZER ORTHOPEDIC INTER-OP ACETABULAR SHELL REMOVED IN THIS PROCEDURE IN SULZER'S RECENT ALERT. THE PROBLEMS PT EXPERIENCED WAS RELATED TO THE DESCRIBED PROBLEMS IN THE ALERT ISSUED BY SULZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6396 SULZER MEDICA INTER-OP PORUS SHELL KWB SULZER MEDICA * 144695-CA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR