BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-CONSTRAINED CONDYLAR KNEE (LCCK) ARTI

    MDR report key: 1020355 · Received March 27, 2008

    Report

    Report Number
    1822565-2008-00128
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 27, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: LAB EXAMINATION OF THE SCREW FRACTURE SURFACE INDICATES THAT THE FRACTURE OCCURRED BY TORSIONAL OVERLOAD. IT IS POSSIBLE THAT THE LOCKING SCREW WAS TIGHTENED MORE THAN THE RECOMMENDED TORQUE OF 94 IN-LBS AND FRACTURED DUE TO OVER-TIGHTENING. EVAL: SCANNING ELECTRON MICROSCOPY ANALYSIS OF THE SCREW FRACTURE SURFACE SHOWED ELONGATED DIMPLES ALONG THE CIRCUMFERENTIAL DIRECTION AND A SMALL REGION OF FINAL FRACTURE SHOWING EQUIAXED DIMPLES. ENERGY DISPERSIVE SPECTROSCOPY ANALYSIS OF THE SCREW MATERIAL SHOWED TI, AL, AND V ELEMENTAL PEAKS TYPICAL OF TIVANIUM ALLOY. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. THERE IS NO INDICATION THAT DESIGN OR MANUFACTURER CONTRIBUTED TO THIS OUTCOME. 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 SURGICAL PROCEDURE BEING PERFORMED IN 2008, THE LOCKING SCREW BROKE OFF AT THE THREAD LEVEL INTO THE STEM EXTENSION. THE SURGEON HAD TO REMOVE TIBIAL AND BLOCK THAT WERE ALREADY CEMENTED IN. THIS DELAYED THE SURGERY. HE WAS ABLE TO REUSE THE TIBIA AND BLOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-CONSTRAINED CONDYLAR KNEE (LCCK) ARTI KNEE PROSTHESIS JWH ZIMMER, INC. NA 54809600V

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R