BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION TIBIAL AUGMENTATION SIZE 4/5MM

    MDR report key: 9150286 · Received October 3, 2019

    Report

    Report Number
    3005180920-2019-00845
    Event Type
    Injury
    Date Received
    October 3, 2019
    Date of Event
    September 6, 2019
    Report Date
    October 3, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825712
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 12 SEPTEMBER 2019. LOT 162447: 24 ITEMS MANUFACTURED AND RELEASED ON 11-MAY-2016. EXPIRATION DATE: 2021-04-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 13 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT (REPORTED IN THIS COMPLAINT). OTHER DEVICES INVOLVED IN THE EVENT: GMK-REVISION 02.07.FCL18105 EXTENSION STEM - FLUTED Ø 18 L 105 LOT. 172187 (K120790). BATCH REVIEW PERFORMED ON 12 SEPTEMBER 2019. 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, 27 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT. GMK-REVISION 02.07.2404R FEMUR REVISION PS SIZE 4 R LOT. 172143 (K102437). BATCH REVIEW PERFORMED ON 12 SEPTEMBER 2019. LOT 172143: 15 ITEMS MANUFACTURED AND RELEASED ON 31-JUL-2017. EXPIRATION DATE: 2022-07-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 11 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-REVISION 02.07.FCL13105 EXTENSION STEM - FLUTED Ø 13 L 105 LOT. 162539 (K120790). BATCH REVIEW PERFORMED ON 12 SEPTEMBER 2019. LOT 162539: 52 ITEMS MANUFACTURED AND RELEASED ON 26-JUL-2016. EXPIRATION DATE: 2021-07-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 41 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT. GMK-REVISION 02.07.0684R REVISION FIXED TIBIAL TRAY CEMENTED SIZE 4 R LOT. 162506 (K123721). BATCH REVIEW PERFORMED ON 12 SEPTEMBER 2019. LOT 162506: 30 ITEMS MANUFACTURED AND RELEASED ON 17-JUN-2016. EXPIRATION DATE: 2021-06-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 28 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-REVISION 02.07.404FDW FEMORAL WEDGE DISTAL SIZE 4/4MM LOT. 162591 (K102437). BATCH REVIEW PERFORMED ON 12 SEPTEMBER 2019. LOT 162591: 26 ITEMS MANUFACTURED AND RELEASED ON 26-JUL-2016. EXPIRATION DATE: 2021-07-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 19 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-REVISION 02.07.404FDW FEMORAL WEDGE DISTAL SIZE 4/4MM LOT. 103626 (K102437). BATCH REVIEW PERFORMED ON 12 SEPTEMBER 2019. LOT 103626: 10 ITEMS MANUFACTURED AND RELEASED ON 12-NOV-2010. EXPIRATION DATE: 2021-07-03. TO DATE, 6 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. 3 DEVICES HAVE BEEN RE-STERILIZED AND RELEASED ON 17-JUN-2016 .EXPIRATION DATE: 2021-05-23. (THESE IS THE RE-STERILIZED LOT INVOLVED IN THIS CASE). TO DATE, 1 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD. 1 DEVICE HAS BEEN RE-STERILIZED AND RELEASED ON 04-OCT-2016 .EXPIRATION DATE: 2021-09-13. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD. GMK-REVISION 02.07.0410SCF FIXED TIBIAL INSERT SC SIZE 4/10MM LOT. 161786 (K103170). BATCH REVIEW PERFORMED ON 12 SEPTEMBER 2019. LOT 161786: 10 ITEMS MANUFACTURED AND RELEASED ON 06-JUN-2016. EXPIRATION DATE: 2021-05-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 6 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT. GMK-REVISION 02.07.0005 OFFSET CONNECTOR 5 MM LOT. 178309 (K102437). BATCH REVIEW PERFORMED ON 12 SEPTEMBER 2019. LOT 178309: 35 ITEMS MANUFACTURED AND RELEASED ON 12-MAR-2018. EXPIRATION DATE: 2023-02-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 31 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 AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER ALMOST 1 YEAR AND 2 MONTHS AFTER PREVIOUS SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947984 GMK-REVISION TIBIAL AUGMENTATION SIZE 4/5MM TIBIAL AUGMENTATION KRO MEDACTA INTERNATIONAL SA 162447 07630030825712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention