BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 149107 · Received January 8, 1998

    Report

    Report Number
    149107
    Event Type
    Injury
    Date Received
    January 8, 1998
    Date of Event
    November 7, 1997
    Report Date
    December 4, 1997
    Manufacturer
    INTERMEDICS
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT IS 53 YR OLD DIABETIC WHO WAS INJURED ON THE JOB ON 02/02/1992 WHILE WORKING. SHE SUBSEQUENTLY DEVELOPED POST-TRAUMATIC ARTHRITIS IN HER LEFT KNEE AS A RESULT OF THIS INJURY. SHE UNDERWENT HIGH TIBIAL OSTEOTOMY SEVERAL YRS AGO, WHICH GAVE HER APPROX 2-3 YRS OF RELIEF. SHE HAS NOW DETERIORATED RADIOGRAPHICALLY AND CLINICALLY. SHE WAS ADMITTED FOR REMOVAL OF THE TIBIAL OSTEOTOMY PLATE AND A LEFT TOTAL KNEE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * Implant 5 HOLE PLATE & SCREWS (60MM, 30MM, 32MM, 42MM, 44MM) HRS INTERMEDICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention