BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOLOC II TOTAL CONDYLAR TIBIAL INSERT

    MDR report key: 42531 · Received October 7, 1996

    Report

    Report Number
    1043534-1996-00026
    Event Type
    Injury
    Date Received
    October 7, 1996
    Date of Event
    April 1, 1996
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC
    Product Code
    JWH
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION STATEMENT: RECORDS REVIEWED OF PRODUCT LOT FILE AND FOUND TO BE COMPLETE, ACCURATE, AND ACCEPTABLE. PRODUCT WAS MANUFACTURED AND SOLD BY DOW CORNING WRIGHT, THE ASSETS OF WHICH WERE PURCHASED BY WRIGHT MEDICAL TECHNOLOGY, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOLOC II TOTAL CONDYLAR TIBIAL INSERT Implant KNEE COMPONENT - DEVICE 1 JWH WRIGHT MEDICAL TECHNOLOGY, INC NA M277820

    Patients

    Seq Age Sex Outcome Treatment
    1