BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR-FLEX FEMORAL COMPONENT

    MDR report key: 2932501 · Received January 24, 2013

    Report

    Report Number
    1822565-2013-00163
    Event Type
    Injury
    Date Received
    January 24, 2013
    Report Date
    December 27, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES, PHOTOS, PATIENT FACTOR INFORMATION, SURGICAL NOTES OF X-RAYS WERE RECEIVED. PAIN CAN BE INFLUENCED BY MANY FACTORS. THESE FACTORS INCLUDE, BUT ARE NOT LIMITED TO, PATIENT WEIGHT, PATIENT ACTIVITY, BONE QUALITY, IMPLANT SIZE, SURGICAL TECHNIQUE, AND REHABILITATION PROGRAM. THEREFORE, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. HOWEVER, THE COMPLAINT MAY BE REVISED UPON RETURN OF OPERATIVE REPORTS, X-RAYS AND/OR PRODUCT OR FURTHER PATIENT INFORMATION. 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 OF 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 IN (B)(6) 2011, DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34574 NEXGEN CR-FLEX FEMORAL COMPONENT MBH ZIMMER, INC. 61093952

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention