BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-HINGE FEMORAL COMPONENT SIZE 5 RIGHT

    MDR report key: 7040106 · Received November 17, 2017

    Report

    Report Number
    3005180920-2017-00671
    Event Type
    Injury
    Date Received
    November 17, 2017
    Date of Event
    October 20, 2017
    Report Date
    January 18, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825484
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SECOND REVISION SURGERY UNDERWENT BY THE PATIENT. HE HAD A PRIMARY SURGERY ON AN UNKNOWN DATE, THEN HE WAS REVISED ON (B)(6) 2015 AND NOW HE WAS REVISED AGAIN. THE PATHOGEN IS UNKNOWN. BATCH REVIEWS PERFORMED ON 27 OCTOBER 2017. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 MARCH 2014. EXPIRATION DATE: 2019-02-28. 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 FIXED TIBIAL TRAY SIZE 4 RIGHT, CODE 02.09.4004R, LOT. 146238 (K130299) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 NOVEMBER 2014. EXPIRATION DATE: 2019-10-31. 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 FIXED TIBIAL INSERT SIZE 4/17MM, CODE 02.09.0417H, LOT. 120026AR (K130299) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 MARCH 2014. EXPIRATION DATE: 2017-03-31. 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. 148065 (K102437) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 MARCH 2015. EXPIRATION DATE: 2020-02-29. 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. 148697 (K102437) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 APRIL 2015. EXPIRATION DATE: 2020-02-29. 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 - FLUTED Ø 15 L 150, CODE 02.07.FCL15150, LOT. 140435 (K120790) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 APRIL 2014. EXPIRATION DATE: 2019-03-31. 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 THIS LOT. GMK-HINGE EXTENSION STEM - CEMENTED Ø 13 L 105, CODE 02.07.FSC13105, LOT. 115060 (K120790) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 APRIL 2012. EXPIRATION DATE: 2017-02-28. 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 PATELLA RESURFACING SIZE 3, CODE 02.07.0035RP, LOT. 145648 (K090988) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 NOVEMBER 2014. EXPIRATION DATE: 2019-09-30. 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 THIS LOT. GMK-HINGE FEMORAL WEDGE POSTERIOR SIZE 5/5MM, CODE 02.05.05PW, LOT. 142960 (K102437) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 JUNE 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 WEDGE DISTAL SIZE 5/12MM, CODE 02.07.512FDW, LOT. 110098 (K102437) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30 MAY 2011. EXPIRATION DATE: 2016-04-30. 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 TIBIAL AUGMENTATION SIZE 4/10MM, CODE 02.09.TA410, LOT. 146737 (K130299) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 NOVEMBER 2014. EXPIRATION DATE: 2019-09-30. 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 TIBIAL AUGMENTATION SIZE 4/10MM, CODE 02.09.TA410, LOT. 112189 (K130299) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 OCTOBER 2011. EXPIRATION DATE: 2016-08-31. 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.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE EXPLANTED DEVICES MADE ON (B)(6) 2018 BY THE R&D PROJECT MANAGER: GMK-HINGE IMPLANTS EXPLANTED 2 YEARS AND 1 MONTH AFTER PREVIOUS REVISION SURGERY. THE ARTICULAR SURFACES OF THE EXPLANTED PE LINER WERE FOUND REGULARLY WORN OUT. BONE CEMENT WAS STILL ADHERENT TO THE INNER SURFACES OF THE FEMORAL COMPONENT AND ITS CEMENTED EXTENSION STEM AND ALSO TO THE DISTAL PLANE OF THE TWO WEDGES. EXTENSION STEMS WERE FOUND WELL FIXED TO BOTH FEMORAL AND TIBIAL COMPONENTS. FROM THE VISUAL INSPECTION WAS NOT POSSIBLE TO IDENTIFY POTENTIAL ROOT CAUSES OF THE INFECTION FOR WHICH THE REVISION SURGERY WAS NEEDED.

    Description of Event or Problem · 1

    PROSTHESIS WAS EXPLANTED DUE TO A REPEAT INFECTION. THE COMPLETE PROSTHESES HAS BEEN EXPLANTED AND A CEMENT SPACER WITH ANTIBIOTIC HAS BEEN PUT IN. THE PATHOGEN IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819878 GMK-HINGE FEMORAL COMPONENT SIZE 5 RIGHT KNEE FEMORAL COMPONENT CEMENTED KRO MEDACTA INTERNATIONAL SA 140413 07630030825484

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention