BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR- FLEX FEMORAL COMPONENT

    MDR report key: 2100525 · Received May 17, 2011

    Report

    Report Number
    1822565-2011-01195
    Event Type
    Injury
    Date Received
    May 17, 2011
    Report Date
    April 18, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: PRE-OP AND POST OP X-RAYS ARE NOT AVAILABLE TO STUDY THE FIXATION AND CONFIRM THE PRESENCE OF RADIOLUCENCY AROUND THE FEMORAL COMPONENT. THERE IS ALSO NO ADDITIONAL INFORMATION ON SURGERY/PATIENT CHARACTERISTICS AND POST-OPERATIVE TREATMENT. THE PRODUCTS USED ARE IN PROPER COMBINATION. FEMORAL COMPONENT LOOSENING, IN GENERAL, CAN BE DUE TO MANY FACTORS INCLUDING, BUT NOT LIMITED TO, SURGICAL TECHNIQUE USED, INSUFFICIENT BONE CONTACT WITH THE IMPLANT, MICROMOTION, PATIENT ACTIVITY, OR PATIENT WEIGHT. FURTHER INVESTIGATION CAN BE PERFORMED IF THE X-RAYS AND OTHER INFORMATION ARE MADE AVAILABLE. HOWEVER, GIVEN THE NUMBER OF POSSIBLE PERMUTATIONS THAT COULD LEAD TO FEMORAL LOOSENING, THE EXACT CAUSE OF FAILURE CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. EVALUATION: DEVICE HISTORY RECORDS WERE REVIEWED AND THEY ARE CONFORMING TO MANUFACTURING AND PACKAGING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS PRESENTED WITH RADIOLUCENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN CR- FLEX FEMORAL COMPONENT MBH ZIMMER INC 61098641

    Patients

    Seq Age Sex Outcome Treatment
    1 Other