BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOLOC ADVANTIM ALL POLY PATELLA

    MDR report key: 98618 · Received June 11, 1997

    Report

    Report Number
    1043534-1997-00068
    Event Type
    Injury
    Date Received
    June 11, 1997
    Date of Event
    April 22, 1997
    Report Date
    June 9, 1997
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT RETURNED FOR INVESTIGATION. PRODUCT WAS MFG AND SOLD BY DOW CORNING WRIGHT, THE ASSETS OF WHICH WERE PURCHASED BY WRIGHT MED TECHNOLOGY, INC.

    Description of Event or Problem · 1

    PATELLA-RIGHT FEMORAL PAIN-FALL AT HOME ON RIGHT KNEE 11/11/96. HISTORY OF ARTHRITIS-HYPERTENSION-THROMBOLPHLEBITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOLOC ADVANTIM ALL POLY PATELLA Implant KNEE COMPONENT JWH WRIGHT MEDICAL TECHNOLOGY, INC. NA 072M765650

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R