BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEXGEN CR-FLEX FEMORAL COMPONENT

    MDR report key: 2023283 · Received February 15, 2011

    Report

    Report Number
    1822565-2011-00584
    Event Type
    Injury
    Date Received
    February 15, 2011
    Report Date
    October 20, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FORM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: FEMORAL COMPONENT LOOSENING, IN GENERAL, CAN BE DUE TO MANY FACTORS INCLUDING, BUT NOT LIMITED TO, INSUFFICIENT BONE CONTACT WITH THE IMPLANT, SURGICAL TECHNIQUE, MICROMOTION, PT ACTIVITY, OR PT WEIGHT. GIVEN THE NUMBER OF POSSIBLE PERMUTATIONS THAT COULD LEAD TO FEMORAL LOOSENING, THE EXACT CAUSE OF FAILURE CANNOT BE CONCLUSIVELY DETERMINED. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. 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 AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED. THIS MDR WAS IDENTIFIED DURING AN INTERNAL REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED LATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED FOR LOOSENING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention