BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX FEMORAL COMPONENT

    MDR report key: 2051053 · Received April 5, 2011

    Report

    Report Number
    1822565-2011-00834
    Event Type
    Injury
    Date Received
    April 5, 2011
    Report Date
    March 7, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: IMPLANT COMPATIBILITY WAS CONFIRMED. NEITHER X-RAYS NOR OPERATIVE NOTES WERE PROVIDED. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, AND TYPE OF ACTIVITY (LOW IMPACT VS HIGH IMPACT) ARE UNK. BASED ON THE AVAILABLE INFO, AN EXACT CAUSE FOR THE REPORTED CONDITION 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 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 RE-OPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT'S KNEE WAS REVISED IN 2007 DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX FEMORAL COMPONENT JWH ZIMMER, INC. 60104707

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CAT #00598004701, LOT #60083157| NEXGEN LPS-FLEX ARTICULAR SURFACE| CAT #00596004010, LOT #60110209| NEXGEN STEMMED TIBIAL COMPONENT PRECOAT