BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED TIBIAL COMPONENT

    MDR report key: 2010515 · Received March 1, 2011

    Report

    Report Number
    1822565-2011-00448
    Event Type
    Injury
    Date Received
    March 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NO PARTS WERE RETURNED FOR EVAL. REVISION STATUS IS UNK. WITHOUT ADD'L INFO, THE EXACT CAUSE CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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 WAS REPORTED THAT THE PT IS EXPERIENCING KNEE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN STEMMED TIBIAL COMPONENT JWH ZIMMER, INC. 61497455

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CATALOG # 00595201605, LOT # 61209270| CATALOG # 00595204010, LOT # 61512088| LOT #61504292, MFG AT ZIMMER BV, (B)(4)| NEXGEN ALL POLY PATELLA, CATALOG # 00597206535,| NEXGEN PROLONG CR ARTICULAR SURFACE| NEXGEN CR-FLEX FEMORAL COMPONENT,