BEUDAMED
    FDA Adverse Event Other Summary report: N

    APR STANDARD ENHANCED ACTETABULAR INSERT 28MM/55MM

    MDR report key: 99270 · Received June 20, 1997

    Report

    Report Number
    2935620-1997-00017
    Event Type
    Other
    Date Received
    June 20, 1997
    Date of Event
    April 11, 1997
    Report Date
    June 20, 1997
    Manufacturer
    SULZER ORTHOPEDICS, INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVISED DUE TO LEG LENGTH DISCREPANCY FOLLOWING RIGHT TOTAL HIP REPLACEMENT AND PELVIC OBLIQUITY NOTED IN PT RECORDS AT 6 MONTH EVALUATION ON 1/28/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APR STANDARD ENHANCED ACTETABULAR INSERT 28MM/55MM Implant HIP INSERT PROSTHESIS LZO SULZER ORTHOPEDICS, INC. NA 1200697

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other 4310-02-055| 7354-02-200| 7676-28-400