BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX GSF FEMORAL COMPONENT

    MDR report key: 2023293 · Received February 15, 2011

    Report

    Report Number
    1822565-2011-00569
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    August 17, 2009
    Report Date
    September 2, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: NO DEVICES OR IMAGES HAVE BEEN RETURNED FOR EVALUATION. THE PT IS DESCRIBED AS HAVING A LARGE BUILD AND LOW ACTIVITY LEVEL. IT IS PROBABLE THAT THE DISLOCATION OCCURRED DUE TO THE FALL THAT THE PT EXPERIENCED AS WELL AS PT CHARACTERISTICS. WITHOUT FURTHER INFORMATION, HOWEVER, AN EXACT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED. EVALUATION: 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 ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED. THIS MDR WAS IDENTIFIED DURING AN INTERNAL REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED LATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED FOR DISLOCATION CAUSED BY HYPERFLEXION DUE TO A FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX GSF FEMORAL COMPONENT JWH ZIMMER, INC. 61066306

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention POSTERIOR STABILIZED LPS-FLEX ARTICULAR SURFACE,| CATALOG #00596403012, LOT #61162641| NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-