BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/10MM

    MDR report key: 9410171 · Received December 4, 2019

    Report

    Report Number
    3005180920-2019-01009
    Event Type
    Injury
    Date Received
    December 4, 2019
    Date of Event
    November 4, 2019
    Report Date
    December 4, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817656
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 07 NOVEMBER 2019: LOT 175591: 25 ITEMS MANUFACTURED AND RELEASED ON 23-OCT-2017. EXPIRATION DATE: 2022-10-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 15 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED IN THE COMPLAINT BATCH REVIEWS PERFORMED ON 07 NOVEMBER 2019: GMK-REVISION 02.07.CS20 CENTRED 3DMETAL TIBIAL CONE S H20 (K170149) LOT 163587: 48 ITEMS MANUFACTURED AND RELEASED ON 15-DEC-2016. EXPIRATION DATE: 2021-11-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 36 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 3 OTHER SIMILAR REPORTED EVENTS. GMK-REVISION 02.07.0684L REVISION FIXED TIBIAL TRAY CEMENTED SIZE 4 L (K123721) LOT 175588: 20 ITEMS MANUFACTURED AND RELEASED ON 05-DEC-2017. EXPIRATION DATE: 2022-11-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 16 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-REVISION 02.07.0005 OFFSET CONNECTOR 5 MM (K102437) LOT 173108: 50 ITEMS MANUFACTURED AND RELEASED ON 23-OCT-2017. EXPIRATION DATE: 2022-10-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 49 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-REVISION 02.07.FCL14150 EXTENSION STEM - FLUTED Ø 14 L 150 (K120790) LOT 143690: 10 ITEMS MANUFACTURED AND RELEASED ON 12-SEP-2014. EXPIRATION DATE: 2019-07-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 8 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-REVISION 02.09.TA410 TIBIAL AUGMENTATION SIZE 4/10MM (K130299) LOT 167711: 24 ITEMS MANUFACTURED AND RELEASED ON 25-JAN-2017. EXPIRATION DATE: 2022-01-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 16 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT. TWO EQUAL DEVICES REPORTED IN THIS COMPLAINT. GMK-REVISION 02.07.2405L FEMUR REVISION PS SIZE 5 L (K102437) LOT 173070: 24 ITEMS MANUFACTURED AND RELEASED ON 26-SEP-2017. EXPIRATION DATE: 2022-09-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 16 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-REVISION 02.07.0003 OFFSET CONNECTOR 3 MM (K102437) LOT 178290: 50 ITEMS MANUFACTURED AND RELEASED ON 07-MAR-2018. EXPIRATION DATE: 2023-02-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 45 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-REVISION 02.07.FCL18105 EXTENSION STEM - FLUTED Ø 18 L 105 (K120790) LOT 172187: 35 ITEMS MANUFACTURED AND RELEASED ON 12-JUL-2017. EXPIRATION DATE: 2022-07-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 28 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 2 OTHER SIMILAR REPORTED EVENTS. GMK-REVISION 02.05.05PW FEMORAL WEDGE POSTERIOR SIZE 5/5MM (K102437) LOT 173965: 24 ITEMS MANUFACTURED AND RELEASED ON 28-AUG-2017. EXPIRATION DATE: 2022-08-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 14 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT. GMK-REVISION 02.05.05DW FEMORAL WEDGE DISTAL SIZE 5/8MM (K102437) LOT 173129: 27 ITEMS MANUFACTURED AND RELEASED ON 19-JUL-2017. EXPIRATION DATE: 2022-07-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 13 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT. GMK-REVISION 02.05.05DW FEMORAL WEDGE DISTAL SIZE 5/8MM (K102437) LOT 178530: 18 ITEMS MANUFACTURED AND RELEASED ON 31-JAN-2018. EXPIRATION DATE: 2023-01-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 8 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-REVISION 02.07.510FPW FEMORAL WEDGE POSTERIOR SIZE 5/10MM (K102437) LOT 162584: 24 ITEMS MANUFACTURED AND RELEASED ON 26-JUL-2016. EXPIRATION DATE: 2021-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 7 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION, 1 YEAR AN 1 MONTH AFTER PRIMARY, AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202726 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/10MM KNEE TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 175591 07630030817656

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention