BEUDAMED
    FDA Adverse Event Summary report: N

    SULZER IMPLANT

    MDR report key: 359319 · Received October 29, 2001

    Report

    Report Number
    359319
    Date Received
    October 29, 2001
    Date of Event
    October 23, 2001
    Report Date
    October 24, 2001
    Manufacturer
    SULZER MEDICA, SULZER ORTHOPEDICS INC
    Product Code
    LPH
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INJURY TO FEMORAL HEAD SUSTAINED FOLLOWING FALL AT WORK. PAIN PROGRESSED WITH DECREASED IN MOBILITY OF JOINT. DIAGNOSED WITH CORE DECOMPRESSION AND PHOTOPENIC LESION IN FEMORAL HEAD AFTER PERIOD OF ATTEMPTING TO MANAGE COURSE CONSERVATIVELY PER PT WISHES. REQUESTED NEW DEVICE NOT REPROCESSED DEVICE THAT HAD BEEN INVOLVED IN PRIOR RECALL. PT CONTINUED TO EXPERIENCE SEVERE PAIN AND DECREASED MOBILITY. BONE SCAN DEMONSTRATED A SHARPLY DELINEATED AREA WITH VERY DENSE UPTAKE. MFR IDENTIFIED THE DEVICES HAD BEEN INVOLVED IN THE PRIOR RECALL AND WERE REPROCESSED. MUTUALLY AGREED UPON PLAN TO EXPLANT DEVICE AND PROCEED WITH NEW PROSTHESIS. INCREASING PAIN WITH WEIGHT BEARING LEFT LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48416 SULZER IMPLANT SILZER HIP PROSTHESIS COMPONENTS LPH SULZER MEDICA, SULZER ORTHOPEDICS INC * 1432187-CB
    48417 SULZER IMPLANT SULZER HIP PROSTHESIS COMPONENTS LPH SULZER MEDICA, SULZER ORTHOPEDICS INC * 1417742

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR