BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-HINGE EXTENSION STEM - FLUTED Ø 15 L 105

    MDR report key: 6391297 · Received March 9, 2017

    Report

    Report Number
    3005180920-2017-00097
    Event Type
    Malfunction
    Date Received
    March 9, 2017
    Date of Event
    February 7, 2017
    Report Date
    March 9, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K120790
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 09 FEBRUARY 2017 AND INCLUDES: THE SURGEON CONFIRMED THE FINAL FEMORAL COMPONENT WITH THE ASSEMBLED TRIALS. THEREFORE HE USED THE TRIALS FIRST, IN WHICH HE HAD NO ISSUE WHEN REDUCING THE TRIAL COMPONENTS. THE REAMERS WERE USED TO REAM OUT THE FEMORAL CANAL. THE FINAL REAMER USED WAS A 15X105 SUNK TO THE OFFSET MARK. THE SURGEON ASSEMBLED THE TRIALS (FEMUR+OFFSET+STEM) RELATIVE TO SIZE OF THE FINAL REAMER (15X105) AND ORIENTATION OF THE FEMORAL TRIAL. IN THIS SPECIFIC REVISION CASE, THE FEMORAL CANAL WAS ALREADY DRILLED FROM THE PATIENT'S PREVIOUS SURGERY AROUND 10 YEARS BEFORE. THE SURGEON REMOVED THE CEMENT AND CLEANED OUT THE CANAL WITH A MORELAND CURETTE. THEN HE SEQUENTIALLY REAMED UP TO 15MM WHERE HE RECEIVED FEEDBACK FROM THE CORTICAL BONE AND LEFT THE REAMER IN PLACE TO PROCEED TO THE NEXT STEP. BATCH REVIEW PERFORMED ON 07 MARCH 2017. LOT 162545: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 JULY 2016. EXPIRATION DATE: 2021-07-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ON 09 MARCH 2017 THE R&D PROJECT MANAGER PERFORMED A PRELIMINARY INVESTIGATION BASED ON THE AVAILABLE INFORMATION ABOUT IMPLANT REFERENCE AND LOT NUMBER, AND COMMENTED AS FOLLOWS: FEMORAL COMPONENT PRODUCT LOT NUMBER 162148: FINISHED PRODUCT HAS BEEN MANUFACTURED IN 2016. PRODUCT SPECIFICATIONS HAVEN'T BEEN MODIFIED RECENTLY. FROM THE RELATIVE ROUTE CARD IT CAN BE SEEN THAT THE CASTING COMPONENT LOT NUMBER IS MAT13789, RELATIVE TO A PRODUCT PRODUCED IN 2013 (NO NEWER LOT). OFFSET CONNECTOR LOT NUMBER 165117: FINISHED PRODUCT HAS BEEN PRODUCED IN 2016. PRODUCT SPECIFICATIONS HAVEN'T BEEN MODIFIED RECENTLY. EXTENSION STEM LOT NUMBER 162545: FINISHED PRODUCT HAS BEEN PRODUCED IN 2016. PRODUCT SPECIFICATIONS HAVEN'T BEEN MODIFIED RECENTLY. NO INFORMATION ABOUT LOT NUMBERS OF THE RELATIVE TRIALS USED ARE AVAILABLE. IN ANY CASE NO RECENT MODIFICATIONS HAVE BEEN IMPLEMENTED ON THE TRIALS COMPONENTS. DEVICE NOT EXPLANTED.

    Description of Event or Problem · 1

    WHEN TRYING TO IMPLANT THE FEMORAL STEM, IT DID NOT SEAT PROPERLY INTO THE PREPARED FEMORAL CANAL (15MM REAMER). THE SURGEON CONFIRMED THE POSITION WITH THE ASSEMBLED TRIAL, AND TRIED A SECOND TIME, IN WHICH HE WAS STILL UNSUCCESSFUL IN SEATING THE FINAL COMPONENT. THE SURGEON DECIDED TO REAM WITH AT 16MM REAMER, AT WHICH THE IMPLANT WAS FINALLY ABLE TO BE REDUCED AND SEATED IN ITS FINAL POSITION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174174 GMK-HINGE EXTENSION STEM - FLUTED Ø 15 L 105 KNEE EXTENSION STEM JWH MEDACTA INTERNATIONAL SA 162545

    Patients

    Seq Age Sex Outcome Treatment
    1 Other