BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROT POR SHL W/SEALABLE SCWHLS SZ67MM

    MDR report key: 358343 · Received October 29, 2001

    Report

    Report Number
    2935620-2001-01707
    Event Type
    Injury
    Date Received
    October 29, 2001
    Date of Event
    June 26, 2001
    Report Date
    August 29, 2001
    Manufacturer
    SULZER ORTHOPEDICS, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO SOUS IN 08/2001, THAT THE PATIENT WAS REVISED IN 2000, HOWEVER, THE AGENT DID NOT HAVE ANY OTHER INFORMATION REGARDING WHY THIS PATIENT WAS REVISED. SOUS HAS REQUESTED MORE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48426 PROT POR SHL W/SEALABLE SCWHLS SZ67MM HIP PROSTHESIS JDI SULZER ORTHOPEDICS, INC. NA 1391594

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R