BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 1 RIGHT

    MDR report key: 6029797 · Received October 14, 2016

    Report

    Report Number
    3005180920-2016-00524
    Event Type
    Injury
    Date Received
    October 14, 2016
    Date of Event
    September 16, 2016
    Report Date
    October 14, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K123721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE THIRD REVISION SURGERY UNDERWENT BY THE PATIENT. THE PRIMARY SURGERY WAS PERFORMED ON AN UNKNOWN DATE WITH NON-MEDACTA PRODUCTS. THE FIRST REVISION SURGERY (2 STEPS) TOOK PLACE ON (B)(6) 2016 DUE TO NON-MEDACTA PRODUCT FAILING AND THE PATIENT HAD A MEDACTA ANTIBIOTIC SPACER IMPLANTED. ON (B)(6) 2016 THE SURGEON REMOVED THE ANTIBIOTIC SPACER AND INPUT PERMANENT IMPLANTS. ON (B)(6) 2016 THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATIENT WAS INFECTED WITH PSEUDOMONAS. A SECOND REVISION WAS PERFORMED: THE SURGEON REVISED THE INSERT (MDR 2016-00513). THEN, THE PATIENT CAME IN AGAIN DUE TO SIGNS OF INFECTION. BATCH REVIEWS PERFORMED ON (B)(6) 2016. LOT 122883: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 OCTOBER 2012. EXPIRATION DATE: 2017-09-30. 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-REVISION EXTENSION STEM - FLUTED Ø 12 L 105, CODE 02.07.FCL12105, LOT. 146776 (K120790) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19 JANUARY 2015. EXPIRATION DATE: 2019-12-31. 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-REVISION FEMUR REVISION PS SIZE 2 RIGHT, CODE 02.07.2402R, LOT. 157214 (K102437) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 MARCH 2016. EXPIRATION DATE: 2021-02-03. 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-REVISION EXTENSION STEM - FLUTED Ø 12 L 65, CODE 02.07.FCL12065, LOT. 148693 (K120790) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 APRIL 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-REVISION OFFSET CONNECTOR 3 MM, CODE 02.07.0003, LOT. 156890 (K102437) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 MARCH 2016. EXPIRATION DATE: 2021-02-07. 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 FIXED TIBIAL INSERT SC SIZE 1/14MM, CODE 02.07.0114SCF, LOT. 146757 (K103170) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 JULY 2015. EXPIRATION DATE: 2020-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, THIS IS THE ONLY ITEM SOLD OF THE LOT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE INFECTION HAS BEEN CONFIRMED. THE PATHOGEN RESULT IS PSEUDOMONAS. THE SURGEON REMOVED ALL HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682363 GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 1 RIGHT REVISION FIXED TIBIAL TRAY CEMENTED JWH MEDACTA INTERNATIONAL SA 122883

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention