BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED TIBIAL COMPONENT

    MDR report key: 1990868 · Received February 8, 2011

    Report

    Report Number
    1822565-2011-00202
    Event Type
    Injury
    Date Received
    February 8, 2011
    Report Date
    January 10, 2011
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: ZIMMER HAS INVESTIGATED ON METAL ALLERGY AND SENSITIVITY IN THE PAST AND RECOMMENDS THAT A PT WITH A POTENTIAL METAL SENSITIVITY BE SEEN BY A DERMATOLOGIST OR ALLERGIST AND UNDERGO APPROPRIATE TESTING BEFORE HAVING SURGERY. WITH THE AVAILABLE INFO, A POSSIBLE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT IS PRESENTING WITH SWELLING. NO INFECTION IS PRESENT. PT HAS ALSO HAD TO HAVE INFLAMMATORY FLUID DRAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN STEMMED TIBIAL COMPONENT JWH ZIMMER 61166222

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CATALOG #00596403210, LOT #61200721| NEXGEN LPS-FLEX GSF FEMORAL COMPONENT,| LOT #61189527| NEXGEN ALL POLY PATELLA, CATALOG #00597206532,| LOT #61121340 - MANUFACTURED BY ZIMMER (B)(4)| NEXGEN LPS-FLEX ARTICULAR SURFACE,| MANUFACTURED BY ZIMMER (B)(4)| MANUFACTURED BY ZIMMER (B)(4)| CATALOG #00576401551, LOT #61115599| NEXGEN STEM EXTENSION, CATALOG #00598802011,