BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-HINGE FIXED TIBIAL INSERT SIZE 2/14MM

    MDR report key: 6672558 · Received June 28, 2017

    Report

    Report Number
    3005180920-2017-00340
    Event Type
    Injury
    Date Received
    June 28, 2017
    Date of Event
    May 23, 2017
    Report Date
    August 30, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825064
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 24 AUGUST 2017 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED SCREW AND COMMENTED AS FOLLOWS: THE SCREW IS FOUND BROKEN IN CORRESPONDENCE TO THE SECOND THREADS OF ITS THREADED SHAFT. THIS CORRESPONDS TO THE PART OF THE SCREW THAT STICKS OUT FROM THE BASEPLATE. THE REMAINING PART OF THE SCREW IS NOT AVAILABLE SINCE LEFT INSIDE THE TIBIA BASEPLATE. THE PART OF THE SCREW REMOVED BY ARTHROSCOPY IS NOT DAMAGED. THE SCREW WAS MOST LIKELY FOUND INTO THE INSERT AND NOT LOOSENED IN THE JOINT. WE CAN SO SUPPOSE THAT THE ARTICULAR SURFACE OF THE FEMUR AND THE INSERT HAVE NOT BEEN DAMAGED BY THE SCREW.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2017 AND INCLUDES: ONLY THE SCREW OF THE INLAY IS AVAILABLE FOR INVESTIGATION. THE IMPLANTS HAVE BEEN TAKEN OUT SUCCESSFULLY. BATCH REVIEWS PERFORMED ON (B)(6) 2017. LOT 143009: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 JULY 2014. EXPIRATION DATE: 2019-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD AND THIS IS THE SECOND SIMILAR EVENT REPORTED ON THE SAME LOT. GMK-HINGE EXTENSION STEM - CEMENTED Ø 16 L 105, CODE 02.07.FSC16105, LOT. 153084 (K120790) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 SEPTEMBER 2015. EXPIRATION DATE: 2020-08-24. 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. GMK-HINGE EXTENSION STEM - CEMENTED Ø 13 L 65, CODE 02.07.FSC13065, LOT. 154981 (K120790) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 OCTOBER 2015. EXPIRATION DATE: 2020-10-12. 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. GMK-HINGE FEMORAL WEDGE DISTAL SIZE 3/4MM, CODE 02.07.304FDW, LOT. 130766 (K102437) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 APRIL 2013. EXPIRATION DATE: 2018-02-28. 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. GMK-HINGE OFFSET CONNECTOR 5 MM, CODE 02.07.0005, LOT. 153101 (K102437) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 NOVEMBER 2015. EXPIRATION DATE: 2020-10-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-HINGE FIXED TIBIAL TRAY SIZE 2 LEFT, CODE 02.09.4002L, LOT. 154267 (K130299) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 SEPTEMBER 2015. EXPIRATION DATE: 2020-07-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD AND THIS IS THE SECOND SIMILAR EVENT REPORTED ON ITEMS OF THE SAME LOT. GMK-HINGE FEMORAL WEDGE POSTERIOR SIZE 3/5MM, CODE 02.05.03PW, LOT. 144460 (K102437) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01 JULY 2014. EXPIRATION DATE: 2019-05-31. 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. GMK-HINGE FEMORAL COMPONENT SIZE 3 LEFT, CODE 02.09.2603L, LOT. 153057 (K130299) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 SEPTEMBER 2015. EXPIRATION DATE: 2020-07-31. 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. GMK-HINGE FEMORAL WEDGE POSTERIOR SIZE 3/5MM, CODE 02.05.03PW, LOT. 125264 (K102437) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 JANUARY 2013. EXPIRATION DATE: 2017-12-31. 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. GMK-HINGE OFFSET CONNECTOR 3 MM, CODE 02.07.0003, LOT. 155902 (K102437) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19 OCTOBER 2015. EXPIRATION DATE: 2020-10-03. 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. GMK-PRIMARY PATELLA RESURFACING SIZE 3, CODE 02.07.0035RP, LOT. 156396 (K090988) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 FEBRUARY 2016. EXPIRATION DATE: 2021-01-27. 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. NOT YET RECEIVED.

    Description of Event or Problem · 1

    DURING A REVISION OF GMK HINGE IMPLANTS DUE TO INFECTION, THE SURGEON NOTICED THAT THE SCREW OF THE INLAY WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453070 GMK-HINGE FIXED TIBIAL INSERT SIZE 2/14MM FIXED TIBIAL INSERT KRO MEDACTA INTERNATIONAL SA 143009 07630030825064

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention