BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1121023 · Received August 14, 2008

    Report

    Report Number
    1822565-2008-00517
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Report Date
    August 6, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY - THE REMAINING INVENTORY OF THE COMPLAINT LOT WAS FULLY DISTRIBUTED WITHOUT ANY FURTHER REPORTS OF THIS KIND. THE CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED WITH THE AVAILABLE INFO AND IT DOES NOT APPEAR TO BE A MANUFACTURING OR LABELING ISSUE. EVAL: NO PRODUCT WAS 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 INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PACKAGE WAS FOR AN LPS FLEX ARTICULAR SURFACE EF W/5-6 12MM. INSIDE THE BOX WAS AN LPS-FLEX ARTICULAR SURFACE CD W/3-4 12MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED LPS-FLEX ARTICUL KNEE PROSTHESIS HSA ZIMMER, INC. NA 60928038

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK