BEUDAMED
    FDA Adverse Event Other Summary report: N

    THREADED STRAIGHT SHELL IMPACTOR ROD

    MDR report key: 281841 · Received June 13, 2000

    Report

    Report Number
    2935620-2000-00018
    Event Type
    Other
    Date Received
    June 13, 2000
    Date of Event
    May 12, 2000
    Report Date
    May 15, 2000
    Manufacturer
    SULZER ORTHOPEDICS INC.
    Product Code
    HWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED: RIM FLARE ACETABULAR SHELL COLD WELDED ONTO IMPACTOR INSTRUMENT DURING SURGERY AND CAUSED A DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THREADED STRAIGHT SHELL IMPACTOR ROD ORTHOPEDIC HIP INSTRUMENT HWA SULZER ORTHOPEDICS INC. NA 1298597

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| R 1417244)(5/2000).| 4361-00-053 RIM FLARE POR SHELL INTER-OP (LOT #