BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-HINGE FIXED TIBIAL TRAY SIZE 4 L

    MDR report key: 9932776 · Received April 7, 2020

    Report

    Report Number
    3005180920-2020-00218
    Event Type
    Injury
    Date Received
    April 7, 2020
    Date of Event
    March 9, 2020
    Report Date
    April 7, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825576
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 18 MARCH 2020: LOT 181161: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAY2018. EXPIRATION DATE: 2023-05-06. 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. ADDITIONAL COMPONENTS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 18 MARCH 2020: GMK-HINGE 02.09.2604L FEMORAL COMPONENT SIZE 4 L (K130299). LOT 182049: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JUN-2018. EXPIRATION DATE: 2023-05-24. 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. GMK-HINGE 02.05.04PW FEMORAL WEDGE POSTERIOR SIZE 4/5MM (K102437). LOT 177676: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JAN-2018. EXPIRATION DATE: 2023-01-04. 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-HINGE 02.09.0412H FIXED TIBIAL INSERT SIZE 4/12MM (K130299). LOT 181587: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAY-2018. EXPIRATION DATE: 2023-05-06. 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. GMK-HINGE 02.07.FCL16065 EXTENSION STEM - FLUTED Ø 16 L 65 (K120790). LOT 169010: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-MAR-2017. EXPIRATION DATE: 2022-03-19. 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. GMK-HINGE 02.07.404FDW FEMORAL WEDGE DISTAL SIZE 4/4MM (K102437). LOT 174965: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2017. EXPIRATION DATE: 2022-10-30. 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. GMK-HINGE 02.07.404FDW FEMORAL WEDGE DISTAL SIZE 4/4MM (K102437). LOT 171396: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JUN-2017. EXPIRATION DATE: 2022-05-22. 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. GMK-HINGE 02.05.04PW FEMORAL WEDGE POSTERIOR SIZE 4/5MM (K102437). LOT 172200: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JUL-2017. EXPIRATION DATE: 2022-07-02. 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. GMK-HINGE 02.07.FCL20105 EXTENSION STEM - FLUTED Ø 20 L 105 (K120790). LOT 162554: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-SEP-2016. EXPIRATION DATE: 2021-08-29. 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. GMK-HINGE 02.07.0005 OFFSET CONNECTOR 5 MM (K102437). LOT 178309: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAR-2018. EXPIRATION DATE: 2023-02-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED AFTER 1 YEAR AND 7 MONTHS AFTER THE PRIMARY DUE TO AN INFECTION. THE SURGEON REVISED ALL IMPLANTS, DONE A WASHOUT AND INSTALLED A CEMENT SPACER. THE PATHOGEN IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396219 GMK-HINGE FIXED TIBIAL TRAY SIZE 4 L FIXED TIBIAL TRAY KRO MEDACTA INTERNATIONAL SA 02.09.4004L 181161 07630030825576

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention