BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FEMUR REVISION PS SIZE 6 L

    MDR report key: 7850449 · Received September 6, 2018

    Report

    Report Number
    3005180920-2018-00661
    Event Type
    Injury
    Date Received
    September 6, 2018
    Date of Event
    August 7, 2018
    Report Date
    September 6, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030821462
    PMA / PMN Number
    K102437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 04 SEPTEMBER 2018; LOT 112689A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 OCTOBER 2013. EXPIRATION DATE: 08-31-2018; NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. REVISION FIXED TIBIAL TRAY CEMENTED SIZE 5 L REFERENCE 02.07.0685L (K123721); LOT 122881: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 OCTOBER 2012. EXPIRATION DATE: 09.30.2017; NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-REVISION OFFSET CONNECTOR 3 MM REFERENCE 02.07.0003 (K102437); LOT 150580: (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 SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK REVISION OFFSET CONNECTOR 5 MM REFERENCE 02.07.0005 (K102437); LOT 150581: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 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-REVISION EXTENSION STEM - FLUTED Ø 22 L 105 REFERENCE 02.07.FCL22105 (K120790); LOT 145064: (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 WITHOUT ANY SIMILAR REPORTED EVENT. GMK-REVISION FEMORAL WEDGE POSTERIOR # 6/10MM REFERENCE 02.07.610FPW (K102437); LOT 115115: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 MARCH 2012 EXPIRATION DATE: 2017-01-31 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 FIXED TIBIAL INSERT SC SIZE 5/14MM REFERENCE 02.07.0514SCF (K103170); LOT 125710: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 FEBRUARY 2013. EXPIRATION DATE: 2018-01-31; 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 TIBIAL AUGMENTATION SIZE 5/5MM REFERENCE 02.09.TA505 (K130299); LOT 145124: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 SEPTEMBER 2014. EXPIRATION DATE: 2019-07-31; 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-REVISION TIBIAL AUGMENTATION SCREWED S5 - 5 MM 02.09.TA505 (K130299); LOT 112183: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 DECEMBER 2015. EXPIRATION DATE: 2021-10-30; 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.

    Description of Event or Problem · 1

    ABOUT 3 YEARS AND A HALF AFTER PRIMARY FOR A RELAPSE INFECTION THE SURGEON COMPLETED THE REVISION SURGERY EXPLANTING THE SPACER (IMPLANTED ON AN UNKNOWN DATE) AND IMPLANTED THE DEFINITIVE DEVICES. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694555 GMK-REVISION FEMUR REVISION PS SIZE 6 L FEMUR REVISION PS JWH MEDACTA INTERNATIONAL SA 112689A 07630030821462

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention