BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN CR-FLEX GSF FEMORAL COMPONENT

    MDR report key: 1934465 · Received November 23, 2010

    Report

    Report Number
    1822565-2010-01192
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    September 24, 2010
    Report Date
    October 25, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THERE ARE NO X-RAYS PROVIDED TO UNDERSTAND LOOSENING. IT IS UNK WHETHER ALL OR ONE OF THE COMPONENTS LED TO LOOSENING. ALSO, NO SURGICAL NOTES ARE PROVIDED TO STUDY THE FIXATION AND SURGICAL TECHNIQUE USED. WITH THE AVAILABLE INFO, A DEFINITIVE CAUSE FOR LOOSENING CANNOT BE DETERMINED. EVALUATION: NO PRODUCT WAS RETURNED. 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 IS PRESENTING WITH PAIN AND SWELLING. IT IS ALSO REPORTED THAT A BONE SCAN REVEALED SIGNS OF LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN CR-FLEX GSF FEMORAL COMPONENT KNEE PROSTHESIS JWH ZIMMER, INC. 61066352

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR CATALOG #00598003702, LOT# 61166957| NEXGEN ALL POLY PATELLA| (B)(4)| MANUFACTURED BY ZIMMER (B)(4)| MANUFACTURED BY ZIMMER (B)(4)| NEXGEN STEMMED TIBIAL COMPONENT| CATALOG #00597206529, LOT #61169282