BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENDER SOLUTION NK-FLEX PROLONG ART SURFACE

    MDR report key: 2093433 · Received April 12, 2011

    Report

    Report Number
    1822565-2011-00937
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 16, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    1822565-08/27/2009-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: CAUSE CANNOT BE DEFINITIVELY DETERMINED. IT WAS CONCLUDED THAT THE SURGEON WAS INDEED EXPERIENCING THE PREVIOUSLY ADDRESSED DESIGN ISSUE. THE ARTICULAR SURFACE PERIPHERAL PRESS-FIT WITH THE TIBIAL TRAY CAUSES THE MEDIAL OR LATERAL EDGES OF THE ART SURFACE TO NOT FULLY SEAT. THE SOLUTION TO THIS ISSUE IS THE PERIPHERAL RIB IMPACTOR INSTRUMENT, WHICH IMPACTS THE RAISED SIDE IN ORDER TO FULLY SEAT THE POLY SURFACE. (B)(4). THIS PARTICULAR SURGEON WAS FOUND TO NOT BEING USING THE RECOMMENDED INSTRUMENT FROM THE NOTIFICATION. EVAL: AS RETURNED, THERE IS DAMAGE ON AND AROUND THE LOCKING FEATURE OF THE ARTICULAR SURFACE, CONFIRMING THIS DIFFICULTY. MFG DOCUMENTATION FOR THE REPORTED DEVICES WAS REVIEWED AND INDICATE THEY WERE MFG, INSPECTED, AND PACKAGED TO SPEC.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON WAS UNABLE TO PROPERLY SEAT THE ARTICULAR SURFACE. WHEN ATTEMPTING TO SEAT, THERE WAS AN ASYMMETRIC GAP OF APPROX 1 TO 1.5 MM ON THE MEDIAL SIDE OF THE TIBIAL PLATE. AFTER VERY AGGRESSIVE IMPACTION, THE SURGEON WAS ABLE TO REDUCE THE GAP TO AN ACCEPTABLE LEVEL. IT IS ALSO REPORTED THAT THE SURGEON HAD DIFFICULTIES INSERTING ANOTHER SURFACE OF THE SAME SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENDER SOLUTION NK-FLEX PROLONG ART SURFACE JWH ZIMMER, INC. 61601037

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR GENDER SOLUTION NK-FLEX PROLONG ARTICULAR SURFACE| CATALOG #00542801109, LOT #61642279