BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK HINGE FEMORAL COMPONENT SIZE 2 LEFT

    MDR report key: 5398666 · Received January 29, 2016

    Report

    Report Number
    3005180920-2016-00011
    Event Type
    Injury
    Date Received
    January 29, 2016
    Date of Event
    December 31, 2015
    Report Date
    January 29, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 18 JANUARY 2016, THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: ACCORDING TO REPORT, THIS IS A CONFIRMED INFECTION CASE, AND THEREFORE THE ROOT CAUSE FOR REVISION SHOULD BE CONSIDERED LOCAL INFECTION, A RATHER COMMON EVENT IN REVISION KNEE PROCEDURES. THERE ARE NO REASONS TO SUSPECT THAT THE CAUSE OF THE INFECTION IS IMPLANT-RELATED. BATCH REVIEW PERFORMED ON 25 JANUARY 2016. GMK-HINGE FEMORAL COMPONENT SIZE 2 LEFT, CODE (B)(4), LOT. 151287: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 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 REVISION EXTENSION STEM - CEMENTED Ø 13 L 105, CODE (B)(4), LOT. 152124 ((B)(4)) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 JUNE 2015. EXPIRATION DATE: 2020-05-31. 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-REVISION OFFSET CONNECTOR 5 MM, CODE (B)(4), LOT. 152129 ((B)(4)) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 MAY 2015. EXPIRATION DATE: 2020-03-31. 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 PATELLA RESURFACING SIZE 2, CODE (B)(4), LOT. 142836 ((B)(4) ) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 AUGUST 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 WITHOUT ANY SIMILAR REPORTED EVENT. GMK-REVISION OFFSET CONNECTOR 3 MM, CODE (B)(4), LOT. 150580 ((B)(4) ) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 MAY 2015. EXPIRATION DATE: 2020-03-31. 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 FIXED TIBIAL TRAY SIZE 2 LEFT, CODE (B)(4), LOT. 154267 ((B)(4) ) (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 WITHOUT ANY SIMILAR REPORTED EVENT. GMK-HINGE FIXED TIBIAL INSERT 2/10 MM, CODE (B)(4), LOT. 150740 (N/A) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 APRIL 2015. EXPIRATION DATE: 2020-01-31. 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 REVISION EXTENSION STEM - CEMENTED Ø 13 L 105, CODE (B)(4), LOT. 145039 ((B)(4)) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 SEPTEMBER 2014. EXPIRATION DATE: 2019-08-31. 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. GMK-REVISION FEMORAL WEDGE DISTAL 2/4 MM, CODE (B)(4), LOT. 082545/T () (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 NOVEMBER 2013. EXPIRATION DATE: 2018-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ONLY THIS ITEM OF THIS LOT HAS BEEN ALREADY SOLD. ON 29 JANUARY 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION HERE REPORTED. ON 29 JANUARY 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    REVISION DUE TO INFECTION. EXPLANATION OF THIS GMK HINGE INCL. EVERYTHING. REASON: (B)(6), THE SAME PATHOGEN AS BEFORE (THE 1ST OPERATION WAS DONE ELSEWHERE WITH A NON MEDACTA KNEE; EXPLANTATION IS A 2 STEP REVISION WITH LONG INTERVAL: THE 1ST REVISION WAS THE 1ST OPERATION WITH MEDACTA IMPLANT; NOW THIS IS THE 2ND OPERATION WITH THE EXPLANTATION OF EVERYTHING AND POSITIONING OF CEMENT SPACER). THE RE-IMPLANTATION WAS NOT DEFINED YET. IMPLANTS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57435 GMK HINGE FEMORAL COMPONENT SIZE 2 LEFT HINGE FEMORAL COMPONENT KRO MEDACTA INTERNATIONAL SA 151287

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention