BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/20MM

    MDR report key: 10669527 · Received October 13, 2020

    Report

    Report Number
    3005180920-2020-00716
    Event Type
    Injury
    Date Received
    October 13, 2020
    Date of Event
    September 18, 2020
    Report Date
    October 13, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030816932
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 29 SEPTEMBER 2020: LOT 170558: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-MAR-2017. EXPIRATION DATE: 2022-02-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 4 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 29 SEPTEMBER 2020: GMK-REVISION 02.07.0036RP PATELLA RESURFACING SIZE 4 (K113571) LOT 1907569: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-OCT-2019. EXPIRATION DATE: 2024-09-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 171 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-REVISION 02.07.F11030 PRIMARY EXTENSION STEM Ø11MM / L 30 MM (K133630) LOT. 1907884: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-NOV-2019. EXPIRATION DATE: 2024-11-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 143 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-REVISION 02.07.2403R FEMUR REVISION PS SIZE 3 R (K102437) LOT 1905605: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-OCT-2019. EXPIRATION DATE: 2024-10-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 17 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-REVISION 02.07.0682R REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 (K123721) LOT 1903716: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-SEP-2019. EXPIRATION DATE: 2024-09-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 9 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-REVISION 02.07.FSC13065 EXTENSION STEM - CEMENTED Ø 13 L 65 (K120790) LOT 1903733: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-SEP-2019. EXPIRATION DATE: 2024-09-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 33 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIMARY SURGERY AND WAS IMPLANTED WITH COMPETITOR PRODUCTS. ON (B)(6) 2020, THE PATIENT HAD THE COMPETITOR PRODUCTS REVISED TO MEDATCA PRODUCTS. THE REASON FOR THE REVISION WAS UNKNOWN. PRESENTLY, ON (B)(6) 2020, 7 MONTHS AFTER PREVIOUS SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED ALL GMK-REVISION COMPONENTS TO GMK-HINGE COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1136373 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/20MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.07.0220SCF 170558 07630030816932

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention