BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 505163 · Received January 7, 2004

    Report

    Report Number
    505163
    Event Type
    Injury
    Date Received
    January 7, 2004
    Date of Event
    April 13, 2002
    Report Date
    December 3, 2003
    Manufacturer
    NA
    Product Code
    JDS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT SUSTAINED A FALLING ACCIDENT IN 2001 REQUIRING INTERNAL FIXATION. THE NAIL PLATE FIXATION FAILED EVENTUALLY. PT UNDERWENT BIPOLAR ARTHROPLASTY OF THE LEFT HIP IN 2002. POST OP PT SHOWED GOOD ALIGNMENT OF THE REPLACEMENT BUT STILL HAD QUITE LIMITED MOBILITY AND PAIN. THEREFORE, PT WAS ADMITTED TO REHAB UNIT FOR FURTHER THERAPY. WHILE ON REHAB, DOCTORS SAW PT DAILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK GAMMA NAIL JDS NA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention