BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR-FLEX FEMORAL COMPONENT

    MDR report key: 3820027 · Received May 14, 2014

    Report

    Report Number
    1822565-2014-00614
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    October 21, 2010
    Report Date
    April 18, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: SURGICAL NOTES WERE NOT PROVIDED. RADIOGRAPHS WERE NOT PROVIDED; IT IS UNK 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 INFO PROVIDED. EVAL: 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 ADD'L 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 PATIENT WAS REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288913 NEXGEN CR-FLEX FEMORAL COMPONENT JWH ZIMMER, INC. 61332168

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention LOT # 61522904, CATALOG # 00595403702| NEXGEN TRABECULAR METAL TIBIAL COMPONENT