BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFORMANCE KNEE TIBIAL LOCKING SCREW

    MDR report key: 70626 · Received February 18, 1997

    Report

    Report Number
    70626
    Event Type
    Injury
    Date Received
    February 18, 1997
    Date of Event
    January 10, 1997
    Report Date
    February 6, 1997
    Manufacturer
    KIRSCHNER MEDICAL CORP.
    Product Code
    HSH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN DOING SURGERY REPORTED TO PRODUCT SUPPLIER A POTENTIAL PROBLEM WITH LOCKING SCREW. HOSP UNAWARE. HOSP NOTIFIED ON 2/5/96 FROM SUPPLIER THAT THEY INTENDED TO REPORT. PT HAD PAIN SINCE KNEE REPLACED IN 3/94.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFORMANCE KNEE TIBIAL LOCKING SCREW Implant LOCKING SCREW HSH KIRSCHNER MEDICAL CORP. * 025511

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization