BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE ARTICULAR SURFACE WITH HINGE

    MDR report key: 1262774 · Received December 12, 2008

    Report

    Report Number
    1822565-2008-00904
    Event Type
    Injury
    Date Received
    December 12, 2008
    Date of Event
    November 10, 2008
    Report Date
    November 11, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HRZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY - THE LOOSENING OF THE HINGE POST EXTENSION CAN RESULT IF IT IS INITIALLY UNDER TORQUED. TIGHTENING OF THE HINGE POST EXTENSION TO THE REQUIRED TORQUE OF 130 IN-LBS IS CRITICAL FOR THE PROPER FUNCTIONING OF THE PARTS. IT IS UNKNOWN IF THE HINGE POST EXTENSION WAS INITIALLY TORQUED TO THE REQUIRED 130 IN-LBS. THE PARTS WERE NOT RETURNED AND X-RAYS WERE NOT PROVIDED FOR EVALUATION. THE CAUSE OF THE LOOSENING OF THE HINGE POST EXTENSION COULD BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. 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, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2008 AND WAS REVISED SEVEN MONTHS LATER, DUE TO THE HINGE POST LOOSENING (UNTHREADING) FROM HINGE ASSEMBLY CAUSING KNEE TO DISLOCATE AND POLY TO DISLODGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE ARTICULAR SURFACE WITH HINGE KNEE PROSTHESIS HRZ ZIMMER, INC. NA 60863610

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R