BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR-FLEX FEMORAL COMPONENT POROUS

    MDR report key: 1960970 · Received January 11, 2011

    Report

    Report Number
    1822565-2011-00043
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: THE CAUSE COULD BE MULTI-FACTORIAL. WITHOUT FURTHER INFO ON THE SURGERY AND/OR RETURN OF PRODUCT/X-RAYS, A PROBABLE CAUSE FOR ALLEGED DEFICIENCY CANNOT BE DETERMINED. EVALUATION: MFG RECORDS FOR THE REPORTED DEVICE WAS REVIEWED AND INDICATES THE DEVICE WAS MANUFACTURED, INSPECTED, AND PACKAGED TO SPEC. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. 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 PT WAS REVISED DUE TO THE LOOSENING OF THE FEMORAL COMPONENT. ALLERGIES ARE ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN CR-FLEX FEMORAL COMPONENT POROUS KNEE PROSTHESIS JWH ZIMMER, INC. 60647361

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention