BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR-FLEX GSF FEMORAL COMPONENT

    MDR report key: 2041992 · Received March 31, 2011

    Report

    Report Number
    1822565-2011-00826
    Event Type
    Injury
    Date Received
    March 31, 2011
    Report Date
    March 4, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: SURGEON OBSERVATION ON POST SURGERY STATES X-RAYS TAKEN AT SIX WEEKS LOOK PERFECT AND ONE YEAR F/U X-RAYS SHOW A LOT OF BONE RESORPTION AROUND THE END OF EACH IMPLANT. POST OPERATIVE X-RAYS OF THE RIGHT KNEE EXHIBIT SOME OSTEOLYSIS, BUT DO NOT CLEARLY INDICATE BONE RESORPTION. RADIOLUCENCIES LEADING TO OSTEOLYSIS/COMPONENT LOOSENING, IN GENERAL, CAN BE DUE TO MANY FACTORS INCLUDING, BUT NOT LIMITED TO: INSUFFICIENT BONE CONTACT WITH THE IMPLANT, SURGICAL TECHNIQUE, MICRO-MOTION, PT ACTIVITY, OR PT WEIGHT. WITH THE AVAILABLE INFO, A CONCLUSIVE CAUSE CANNOT BE 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 ADD'L SUBSTANTIVE INFO BE REC'D, 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 OSTEOLYSIS IN HER RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN CR-FLEX GSF FEMORAL COMPONENT MBH ZIMMER, INC. 61115715

    Patients

    Seq Age Sex Outcome Treatment
    1 Other