BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR-FLEX FEMORAL COMPONENT

    MDR report key: 3032215 · Received March 29, 2013

    Report

    Report Number
    1822565-2013-00564
    Event Type
    Injury
    Date Received
    March 29, 2013
    Report Date
    March 1, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A HEALTH PROFESSIONAL WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: NO PRODUCT WAS RECEIVED. COMPONENTS ARE COMPATIBLE PER ZIMMER COMPATIBILITY CHARTS. OPERATIVE NOTES WERE RECEIVED, BUT FROM THE INFO PROVIDED NO DEVIATION FROM THE SURGICAL TECHNIQUE WAS OBSERVED. X-RAYS WERE PROVIDED. IT APPEARS THAT THERE MAY BE OSTEOLYSIS OF THE POSTERIOR CONDYLES BASED ON AN APPARENT WIDENING TRANSLUCENCY OBSERVED ON X-RAYS; HOWEVER, THE FIRST SET OF X-RAYS IS TOO DARK TO DETERMINE IF A TRANSLUCENCY ALREADY EXISTED. REVIEW OF THE COMPLAINT RECORDS FOR THIS PRODUCT DOES NOT REVEAL COMPLAINTS ABOUT CEMENT POCKET DESIGN ISSUES FROM ANY OTHER COMPLAINANTS. CAUSE CANNOT BE DEFINITIVELY DETERMINED. 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 THIS INVESTIGATION TO BE CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT IS EXPERIENCING RADIOLUCENT LINES INDICATING LOOSENING AROUND THE POSTERIOR CONDYLES. IT IS ALSO REPORTED THAT THE CEMENT POCKET IS NOT APPROPRIATELY DESIGNED TO PRESSURIZE THE CEMENT WHEN INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131163 NEXGEN CR-FLEX FEMORAL COMPONENT JWH ZIMMER, INC. 61626156

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other LOT # 70624238| PALACOS R BONE CEMENT: CATALOG #00111214001,