BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR-FLEX FEMORAL COMPONENT

    MDR report key: 2852402 · Received November 27, 2012

    Report

    Report Number
    1822565-2012-02415
    Event Type
    Injury
    Date Received
    November 27, 2012
    Date of Event
    July 9, 2009
    Report Date
    October 29, 2012
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS REC'D FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: REVIEW OF SURGICAL REPORTS PROVIDED INDICATES SURGICAL TECHNIQUE WAS FOLLOWED. CORRECT FIT AND ORIENTATION PER SURGICAL TECHNIQUE COULD NOT BE CHECKED W/O RETURN OF X-RAYS. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL OR TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNK. A DEFINITIVE ROOT CAUSE OF THE REPORTED PAIN AND LOOSENING OF THE TIBIAL COMPONENT CANNOT BE DETERMINED WITH THE INFO PROVIDED. EVAL: 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 WAS REPORTED THAT THE PT'S KNEE WAS REVISED DUE TO PAIN. DURING REVISION, THE FEMORAL COMPONENT WAS NOTED AS GROSSLY LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN CR-FLEX FEMORAL COMPONENT JWH ZIMMER INC 60696464

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention CATALOG #00595003701, LOT #60711162| PALACOS R BONE CEMENT, CATALOG #00111214001,| NEXGEN MIS STEMMED TIBIAL COMPONENT,| (B)(4)| LOT #65404098| (B)(4)