BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1073699 · Received July 1, 2008

    Report

    Report Number
    1822565-2008-00382
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Date of Event
    May 11, 2006
    Report Date
    June 6, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: DEVICE HISTORY RECORDS INDICATE THAT THE PART WAS MANUFACTURED AND PACKAGED TO SPECIFICATIONS. THE LABEL USED FOR THIS LOT OF PARTS CLEARLY SHOWS LEFT FEMORAL COMPONENT. IT APPEARS THAT AN INCORRECT PART WAS IMPLANTED AND THE PROBLEM IS USER CAUSED. EVALUATION: 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 INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED BY PATIENT'S COUNSEL THAT PATIENT UNDERWENT TOTAL RIGHT KNEE REPLACEMENT IN 2006, WHEREIN A LEFT KNEE DEVICE WAS IMPLANTED. PATIENT WAS REVISED FOUR MONTHS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED LPS-FLEX FEMORAL KNEE PROSTHESIS HSA ZIMMER, INC. NA 60311772

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R