BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOLOC II TOTAL CONDYLAR INSERT

    MDR report key: 58091 · Received December 20, 1996

    Report

    Report Number
    1043534-1996-00043
    Event Type
    Injury
    Date Received
    December 20, 1996
    Date of Event
    October 3, 1996
    Report Date
    December 20, 1996
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION STATEMENT: NO CONCLUSION CAN BE DRAWN. 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 PLASTIC INSERT WAS WORN OUT. REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOLOC II TOTAL CONDYLAR INSERT Implant KNEE COMPONENT JWH WRIGHT MEDICAL TECHNOLOGY, INC. NA 340600

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention