BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR-FLEX GSF FEMORAL COMPONENT

    MDR report key: 2950002 · Received February 6, 2013

    Report

    Report Number
    1822565-2013-00228
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    June 17, 2010
    Report Date
    January 8, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NO DEVICES, PHOTOS, PT FACTOR INFO, SURGICAL NOTES OR X-RAYS WERE RECEIVED. PAIN CAN BE INFLUENCED BY MANY FACTORS. THESE FACTORS INCLUDE, BUT ARE NOT LIMITED TO, PT WEIGHT, PT ACTIVITY, BONE QUALITY, IMPLANT SIZE, SURGICAL TECHNIQUE, AND REHABILITATION PROGRAM. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. 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 INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51336 NEXGEN CR-FLEX GSF FEMORAL COMPONENT JWH ZIMMER, INC. 60516803

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATALOG# 00595004701, LOT# 60621128| NEXGEN MIS STEMMED TIBIAL COMPONENT: