BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM PROLONG HIGHLY CROSSLINKED POLYETHYLEN

    MDR report key: 1439098 · Received May 8, 2009

    Report

    Report Number
    1822565-2009-00545
    Event Type
    Malfunction
    Date Received
    May 8, 2009
    Date of Event
    March 4, 2009
    Report Date
    April 9, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVAL SUMMARY: THE N-K II PACKAGE INSERT WARNING SECTION STATES, "DO NOT USE: COMPONENTS FROM OTHER KNEE SYSTEMS (AND VICE VERSA) UNLESS EXPRESSLY LABELED FOR SUCH USE. PREMATURE WEAR OR LOOSENING MAY DEVELOP AND MAY REQUIRE SURGICAL EXPLANTATION. EXCEPTION: THE N-K AND N-K II PATELLAR COMPONENTS MAY BE USED INTERCHANGEABLY." THE N-K FLEX PACKAGE INSERT WARNING SECTIONS STATES "DO NOT USE: N-K FLEX COMPONENTS WITH N-K II COMPONENTS. THEY WERE NOT DESIGNED TO BE COMPATIBLE. EXCEPTION: N-K II TIBIAL BASEPLATE COMPONENTS MAY BE USED WITH N-K FLEX TIBIAL ARTICULAR SURFACE, FEMORAL, AND PATELLAR COMPONENTS. DO NOT USE : COMPONENTS FROM OTHER KNEE SYSTEMS (AND VICE VERSA) UNLESS EXPRESSLY LABELED FOR SUCH USE. PREMATURE WEAR OR LOOSENING MAY DEVELOP AND MAY REQUIRE SURGICAL EXPLANTATION." IN ADDITION TO PACKAGE INSERT WARNINGS, THE SALES REP IDENTIFIED THAT THE N-K FLEX ARTICULAR SURFACE WAS NOT APPROVED TO BE USED WITH THE N-K II FEMUR. 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 INFO 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 ON (B) (6) 2009 IN SPITE OF THE FACT THAT THE IMPLANT DID NOT LOCK DOWN ONTO THE TIBIAL TRAY. ADDITIONALLY, ZIMMER INC. KNEE MARKETING DOES NOT APPROVE THIS DEVICE TO BE USED WITH THE FEMUR THAT WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM PROLONG HIGHLY CROSSLINKED POLYETHYLEN KNEE PROSTHESIS JWH ZIMMER, INC. NA 61075262

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR