BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LPS-FLEX ARTICULAR SURFACE

    MDR report key: 2043147 · Received February 24, 2011

    Report

    Report Number
    1822565-2011-00401
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 27, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THERE WERE NO POST-OP X-RAYS PROVIDED TO STUDY THE TIBIAL FIXATION. IT IS UNKNOWN WHETHER THE TAPER PLUG WAS COMPLETELY SEATED AGAINST THE TIBIAL STEM BEFORE IMPLANTATION. DURING IMPACTION OF THE TIBIAL BASEPLATE, THE TAPER PLUG MIGHT HAVE DETACHED DISTALLY IF THE TAPER WAS NOT SEATED PROPERLY. BASED ON THE AVAILABLE INFORMATION, PROBABLE CAUSE FOR THE ALLEGED EVENT CANNOT BE DETERMINED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LOCKING SCREW FROM TWO DIFFERENT ARTICULAR SURFACES WOULD NOT ENGAGE WITH THE TAPER PLUG. SURGERY WAS COMPLETED WITHOUT THE USE OF A LOCKING SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX ARTICULAR SURFACE JWH ZIMMER, INC. 60248580V

    Patients

    Seq Age Sex Outcome Treatment
    1 CATALOG #00596404120, LOT #60191351V| NEXGEN TAPER STEM PLUG: CATALOG #00596009900| LOT # UNK| NEXGEN LPS-FLEX ARTICULAR SURFACE