BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNEX KNEE

    MDR report key: 4112876 · Received September 17, 2014

    Report

    Report Number
    9613350-2014-03884
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, THE DEVICE HAS NOT BEEN RECEIVED FOR INVESTIGATION. NEITHER X-RAYS, NO OTHER SOURCE DOCUMENTS WERE MADE AVAILABLE FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. WHILE A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, AN UPDATED REPORT WILL BE SUBMITTED ONCE ADDITIONAL SUBSTANTIVE INFORMATION IS RECEIVED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH AN INNEX KNEE GENERIC (EXACT DEVICE NAME NOT REPORTED) ON AN UNKNOWN DATE. DUE TO LOOSENING OF TWO TIBIAL PLATES, THE PATIENT UNDERWENT REVISION SURGERY ON AN UNKNOWN DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577100 INNEX KNEE NONE JWH ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R