BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-HINGE FIXED TIBIAL TRAY SIZE 1 R

    MDR report key: 12438304 · Received September 8, 2021

    Report

    Report Number
    3005180920-2021-00709
    Event Type
    Injury
    Date Received
    September 8, 2021
    Date of Event
    August 9, 2021
    Report Date
    September 8, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825521
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW WAS PERFORMED ON 06 SEPTEMBER 2021: LOT 164808: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 7-SEP-2016. EXPIRATION DATE: 2021-08-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) TEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2017. ADDITONAL IMPLANT INVOLVED: GMK-HINGE 02.07.0003 OFFSET CONNECTOR 3 MM (K102437) LOT. (B)(4) BATCH REVIEW WAS PERFORMED ON 06 SEPTEMBER 2021: LOT 187637: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 7-NOV-2018. EXPIRATION DATE: 2023-10-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITONAL IMPLANT INVOLVED: GMK-HINGE 02.07.FCL14065 EXTENSION STEM - FLUTED ¿ 14 L 65 (K120790) LOT. 165108 BATCH REVIEW WAS PERFORMED ON 06 SEPTEMBER 2021: LOT 165108: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-NOV-2016. EXPIRATION DATE: 2021-11-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2017. ADDITONAL IMPLANT INVOLVED: GMK-HINGE 02.09.0114H FIXED TIBIAL INSERT SIZE 1/14MM (K130299) LOT. 162427 BATCH REVIEW WAS PERFORMED ON 06 SEPTEMBER 2021: LOT 162427: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 9-MAY-2016. EXPIRATION DATE: 2021-04-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEM OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2017. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR 2.5 YEARS AFTER TKA (PRESUMABLY REVISION), THE PATIENT FEELS DISCOMFORT AND THE SURGEON DECIDES TO RE-POSITION THE TIBIAL COMPONENT TO GIVE MORE VARUS. THE SURGEON CONFIRMED THE PROSTHESIS WAS NOT FOUND LOOSE. NO REASON TO SUSPECT A FAULTY DEVICE AT THE ORIGIN OF THIS REOPERATION.

    Description of Event or Problem · 1

    2 YEARS AND 7 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT HAD PAIN AND SUSPECTED A LOOSE PROSTHESIS. THE PROSTHESIS WAS NOT LOOSE BUT THE SURGEON DECIDED TO EXPLANT THE TIBIA AND BUILD MORE VARUS WITH THE NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337644 GMK-HINGE FIXED TIBIAL TRAY SIZE 1 R CEMENTED FIXED TIBIAL TRAY KRO MEDACTA INTERNATIONAL SA 02.09.4001R 164808 07630030825521

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention