BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR-FLEX FEMORAL COMPONENT

    MDR report key: 2800968 · Received October 18, 2012

    Report

    Report Number
    3007963827-2012-00014
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    June 6, 2012
    Report Date
    September 18, 2012
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. SURGICAL NOTES AND X-RAYS WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OR PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, 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 REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN CR-FLEX FEMORAL COMPONENT JWH ZIMMER 61469737

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention