BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOLOC II POST STAB TIBIAL INSERT

    MDR report key: 147397 · Received February 3, 1998

    Report

    Report Number
    1043534-1998-00015
    Event Type
    Injury
    Date Received
    February 3, 1998
    Date of Event
    September 1, 1997
    Report Date
    January 8, 1998
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: USER ERROR CONTRIBUTED TO THE EVENT. PRODUCT WAS MANUFACTURED AND SOLD BY DOW CORNING WRIGHT, THE ASSETS OF WHICH WERE PURCHASED BY WRIGHT MEDICAL TECHNOLOGY, INC.

    Description of Event or Problem · 1

    ALLEGEDLY TIBIAL INSERT WORE THROUGH AND WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOLOC II POST STAB TIBIAL INSERT Implant KNEE COMPONENT JWH WRIGHT MEDICAL TECHNOLOGY, INC. NA 057M157090

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention