BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FEMUR REVISION PS SIZE 6 RIGHT

    MDR report key: 6485192 · Received April 12, 2017

    Report

    Report Number
    3005180920-2017-00175
    Event Type
    Injury
    Date Received
    April 12, 2017
    Date of Event
    March 14, 2017
    Report Date
    April 12, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K102437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 10 APRIL 2017. LOT 148687: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 MARCH 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 FEMORAL WEDGE DISTAL SIZE 6/8MM, CODE 02.05.06DW, LOT. 147458 (K102437). APPROX (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 DECEMBER 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-REVISION OFFSET CONNECTOR 3 MM, CODE 02.07.0003, LOT. 161042 (K102437). APPROX (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 APRIL 2016. EXPIRATION DATE: 2021-03-13. 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 FEMORAL WEDGE POSTERIOR SIZE 6/5MM, CODE 02.05.06PW, LOT. 150604 (K102437). APPROX (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 MAY 2015. EXPIRATION DATE: 2020-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, THIS IS THE ONLY ITEM SOLD OF THE SUBJECT LOT. GMK-REVISION EXTENSION STEM SIZE 22MM / L 105MM, CODE 02.07.F22105, LOT. 062596/T (K102437). APPROX (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 MARCH 2014. EXPIRATION DATE: 2019-01-31. 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 FEMORAL WEDGE POSTERIOR SIZE 6/10MM, CODE 02.07.610FPW, LOT. 144458 (K102437). APPROX (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 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 SIZE 6/4MM, CODE 02.07.604FDW, LOT. 146863 (K102437). APPROX (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 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 FIXED TIBIAL TRAY CEMENTED SIZE 4 RIGHT, CODE 02.07.0684R, LOT. 155554 (K123721). APPROX (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 NOVEMBER 2015. EXPIRATION DATE: 2020-10-31. 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 TIBIAL AUGMENTATION SIZE 4/5MM, CODE 02.09.TA405, LOT. 155948 (K130299). APPROX (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30 OCTOBER 2015. EXPIRATION DATE: 2020-10-17. 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. 161043 (K102437). APPROX (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 APRIL 2016. EXPIRATION DATE: 2021-03-14. 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 S4 - 5 MM, CODE 02.09.TA405, LOT. 123239A (K130299). APPROX (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 JUNE 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 EXTENSION STEM - FLUTED Ø 22 L 65, CODE 02.07.FCL22065, LOT. 160044 (K120790). APPROX (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 APRIL 2016. EXPIRATION DATE: 2021-03-17. 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 INSERT PS FIXED SIZE 4/12MM, CODE 02.07.0412SCF, LOT. 157226 (K103170). APPROX (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 MARCH 2016. EXPIRATION DATE: 2021-03-06. 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 RESULT WILL NOT BECOME AVAILABLE. THE SURGEON REVISED ALL HARDWARE AND INPUT 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
    267146 GMK-REVISION FEMUR REVISION PS SIZE 6 RIGHT KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 148687

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention