BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FEMUR REVISION PS SIZE 2 R

    MDR report key: 9681074 · Received February 7, 2020

    Report

    Report Number
    3005180920-2020-00029
    Event Type
    Injury
    Date Received
    February 7, 2020
    Date of Event
    January 9, 2020
    Report Date
    February 7, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030821394
    PMA / PMN Number
    K102437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15.JAN.2020: LOT 148060: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-DIC-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 OTHER SIMILAR REPORTED EVENT SINCE 2016. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: DELAYED INFECTION IN REVISION TKA, 6 MONTHS AFTER OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING TKA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES. OTHER IMPLANTS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON (B)(6) 2020: GMK-REVISION 02.07.0682R REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 R (K123721) LOT. 155553 LOT 155553: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-OCT-2015. EXPIRATION DATE: 2020-09-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016. GMK-REVISION 02.09.TA210 TIBIAL AUGMENTATION SIZE 2/10MM (K130299) LOT. 189441 (2 ITEMS) LOT 189441: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 2-APR-2019. EXPIRATION DATE: 2024-03-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016. GMK-REVISION 02.07.FSC13065 EXTENSION STEM - CEMENTED Ø 13 L 65 (K120790) LOT. 187623 LOT 187623: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-DEC-2018. EXPIRATION DATE: 2023-11-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016. GMK-REVISION 02.07.FCL10150 EXTENSION STEM - FLUTED Ø 10 L 150 (K120790) LOT. 115689B LOT 115689B: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUL-2018. EXPIRATION DATE: 2023-07-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEM OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016. GMK-REVISION 02.07.0005 OFFSET CONNECTOR 5 MM (K102437) LOT. 1901751 LOT 1901751: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 3-JUN-2019. EXPIRATION DATE: 2024-05-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016. GMK-REVISION 02.05.02PW FEMORAL WEDGE POSTERIOR SIZE 2/5MM (K102437) LOT. 1901759 LOT 1901759: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 7-JUN-2019. EXPIRATION DATE: 2024-05-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016. GMK-REVISION 02.05.02PW FEMORAL WEDGE POSTERIOR # 2/5MM (K102437) LOT. 167150 LOT 167150: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 6-DIC-2016. EXPIRATION DATE: 2021-11-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016. GMK-REVISION 02.05.02DW FEMORAL WEDGE POSTERIOR SIZE 2/5MM (K1024379) LOT. 186641 LOT 186641: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-OCTC-2018. EXPIRATION DATE: 2023-10-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016. GMK-REVISION 02.07.212FDA FEMORAL AUGMENTATION DISTAL SIZE 2/12MM (K163311 ) LOT. 183217 LOT 183217: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JUN-2018. EXPIRATION DATE: 2023-05-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEM OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016. GMK-REVISION 02.07.0217SCF FIXED TIBIAL INSERT SC SIZE 2/17MM (K103170) LOT. 157223 LOT 157223: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-DEC-2015. EXPIRATION DATE: 2020-11-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED AFTER 5 MONTHS FROM THE PREVIOUS REVISION, DUE TO AN ENTEROCOCCUS INFECTION. AFTER MULTIPLE WASHOUTS OF THE WOUND, THE SURGEON DECIDED TO PERFORM A FURTHER REVISION OF THE MEDACTA GMK-REVISION AND INSERTED AN ANTIBIOTIC SPACER BLOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145947 GMK-REVISION FEMUR REVISION PS SIZE 2 R FEMUR REVISION JWH MEDACTA INTERNATIONAL SA 02.07.2402R 148060 07630030821394

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention