BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEV POR SHL W/SEALABLE SCWHLS SZ63MM

    MDR report key: 389307 · Received April 23, 2002

    Report

    Report Number
    2935620-2002-00126
    Event Type
    Injury
    Date Received
    April 23, 2002
    Date of Event
    May 12, 2000
    Report Date
    April 15, 2002
    Manufacturer
    SULZER ORTHOPEDICS, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED: REVISION OF AN INTER-OP REVISION SHELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEV POR SHL W/SEALABLE SCWHLS SZ63MM HIP PROSTHESIS LPH SULZER ORTHOPEDICS, INC. NA 1314838

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R