BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE IMPLANT

    MDR report key: 3812640 · Received May 6, 2014

    Report

    Report Number
    9613350-2014-03496
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE THAT CHANGES THIS ASSESSMENT, AN AMENDED MDR WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT RECEIVED ON UNKNOWN DATE A KNEE IMPLANT. THEN AFTER UNKNOWN DATE IN VIVO ON UNKNOWN DATE A REVISION SURGERY WAS PERFORMED DUE TO UNKNOWN REASON. AT THIS TIME THIS IS THE ONLY INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271707 UNKNOWN KNEE IMPLANT UNKNOWN JWH ZIMMER GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R