BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOD ENHCD INS 32/55 APR

    MDR report key: 363443 · Received December 3, 2001

    Report

    Report Number
    2935620-2001-01727
    Event Type
    Injury
    Date Received
    December 3, 2001
    Date of Event
    April 26, 2000
    Report Date
    November 5, 2001
    Manufacturer
    SULZER ORTHOPEDICS, INC.
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED: THE SURGEON REPLACED THE APR LINER WITH AN INTER-OP LINER. THE FEMORAL STEM AND HEAD WERE REPLACED AS WELL, BUT THE ORIGINAL 12 SLOT SHELL WAS NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54233 HOD ENHCD INS 32/55 APR HIP PROSTHESIS KWB SULZER ORTHOPEDICS, INC. NA 0112981

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization