BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1052833 · Received May 22, 2008

    Report

    Report Number
    1822565-2008-00267
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 5, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: CAUSE CANNOT BE DEFINITIVELY DETERMINED. 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 ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING SURGERY IN 2008, THE SURGEON WAS TRAILING WITH A 10MM ARTICULAR SURFACE AND DECIDED TO IMPLANT A 17MM ARTICULAR SURFACE. SINCE HE WAS TRAILING WITH A 10MM SURFACE, HE DID NOT USE THE TAPER PLUG. HE IMPLANTED THE 17MM SURFACE WITHOUT THE LOCKING SCREW.

    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 60705941

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR