BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 3 RIGHT

    MDR report key: 6975543 · Received October 25, 2017

    Report

    Report Number
    3005180920-2017-00608
    Event Type
    Injury
    Date Received
    October 25, 2017
    Date of Event
    September 25, 2017
    Report Date
    October 25, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819377
    PMA / PMN Number
    K123721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 24 OCTOBER 2017. LOT 156557: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 NOVEMBER 2015. EXPIRATION DATE: 2020-10-27. 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. GMK-REVISION FEMUR REVISION PS SIZE 2 RIGHT, CODE 02.07.2402R, LOT. 162493 (K102437) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 JUNE 2016. EXPIRATION DATE: 2021-06-01. 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 3/17MM, CODE 02.07.0317SCF, LOT. 134139 (K103170) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 DECEMBER 2013. EXPIRATION DATE: 2018-10-31. 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-REVISION FEMORAL WEDGE DISTAL SIZE 2/4MM, CODE 02.07.204FDW, LOT. 140510 (K102437) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 APRIL 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 AND THIS IS THE SECOND SIMILAR EVENT REPORTED ON THIS LOT. GMK-REVISION OFFSET CONNECTOR 3 MM, CODE 02.07.0003, LOT. 162576 (K102437) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 JULY 2016. EXPIRATION DATE: 2021-06-20. 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 11 L 105, CODE 02.07.FCL11105, LOT. 155888 (K120790) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 JANUARY 2016. EXPIRATION DATE: 2020-12-15. 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 SIZE 2/8MM, CODE 02.05.02DW, LOT. 141936 (K102437) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19 MAY 2014. EXPIRATION DATE: 2019-04-30. 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-REVISION OFFSET CONNECTOR 5 MM, CODE 02.07.0005, LOT. 162577 (K102437) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 JULY 2016. EXPIRATION DATE: 2021-06-20. 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 11 L 65, CODE 02.07.FCL11065, LOT. 162532 (K120790) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 JULY 2016. EXPIRATION DATE: 20121-07-07. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND IMPLANTED A SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756223 GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 3 RIGHT TIBIAL TRAY FIXED JWH MEDACTA INTERNATIONAL SA 156557 07630030819377

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention