BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR-FLEX FEMORAL COMPONENT

    MDR report key: 3221534 · Received July 9, 2013

    Report

    Report Number
    1822565-2013-01082
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 12, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT IS NOTED THAT THE TIBIAL COMPONENT WAS DOWN SIZED FROM A 3 TO A 2 AND THE FEMORAL COMPONENT WAS UPSIZED FROM A C TO A D. ONLY ONE X-RAY AT ONE ANGLE WAS PROVIDED SO, FIT AND ORIENTATION CANNOT BE COMPLETELY EVALUATED. NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. TIGHTNESS OF THE KNEE COULD BE CAUSED BY OVERSTUFFING OF THE JOINT, INCORRECT SIZING OF COMPONENTS, OR SCAR TISSUE. WITH THE INFORMATION PROVIDED, IT DOES NOT APPEAR THAT THERE IS A PROBLEM WITH THIS PRODUCT. HOWEVER, THIS CANNOT BE DETERMINED CONCLUSIVELY. 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 IS REPORTED THAT THE PATIENT WAS IMPLANTED IN 2007 AND REVISED DUE TO A TIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312290 NEXGEN CR-FLEX FEMORAL COMPONENT JWH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention