BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED LPS-FLEX ARTICULA

    MDR report key: 1012672 · Received March 12, 2008

    Report

    Report Number
    1822565-2008-00092
    Event Type
    Injury
    Date Received
    March 12, 2008
    Date of Event
    February 2, 2008
    Report Date
    February 14, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE FRACTURED POST WHICH WAS REMOVED DURING SCOPING PROCEDURE WAS NOT RETURNED FOR REVIEW. THE ARTICULATE SURFACE IS STILL IMPLANTED. THE CAUSE OF THE POST FRACTURED COULD NOT BE DEFINITIVELY DETERMINED DUE TO INSUFFICIENT INFORMATION. EVALUATION: NO PRODUCT OR X-RAYS WERE RETURNED. 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 CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2003. ON FEBRUARY 2, 2008, IT IS REPORTED THAT THE POST WAS DISCOVERED TO BE BROKEN AND REMOVED SIX DAYS LATER. POLY EXCHANGE REVISION HAS NOT BEEN SCHEDULED AS OF YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED LPS-FLEX ARTICULA KNEE PROSTHESIS JWH ZIMMER, INC. NA 60003335

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R