BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEXGEN FEMORAL COMPONENT

    MDR report key: 3132971 · Received May 16, 2013

    Report

    Report Number
    1822565-2013-00789
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    April 26, 2011
    Report Date
    April 19, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. NEITHER SURGICAL NOTES NOR X-RAYS WERE PROVIDED; THEREFORE, FIT AND ORIENTATION COULD NOT BE EVALUATED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN, DISCOMFORT, SWELLING AND DIFFICULTY WALKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218497 UNKNOWN NEXGEN FEMORAL COMPONENT KNEE PROSTHESIS JWH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention