BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-HINGE FIXED TIBIAL INSERT SIZE 5/20MM

    MDR report key: 16061012 · Received December 28, 2022

    Report

    Report Number
    3005180920-2022-00980
    Event Type
    Injury
    Date Received
    December 28, 2022
    Date of Event
    December 22, 2022
    Report Date
    December 28, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825293
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19 DECEMBER 2022: LOT 182059: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUNE-2018. EXPIRATION DATE: 2023-06-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDTIONAL COMPONENT INVOLVED: GMK-HINGE 02.09.HE20 GMK-HINGE HINGE POST EXTENSION 20 MM -TINBN COATED (K210010) LOT. 2011024: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-FEB-2021. EXPIRATION DATE: 2026-01-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2022. SUBSEQUENTLY, THE PATIENT CAME IN REPORTING PAIN DUE TO THE KNEE INCISION OPENING UP DURING PHYSICAL THERAPY. ON (B)(6) 2022, THE SURGEON PERFORMED A WASHOUT AND SWAPPED THE POLY. ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND POST EXTENSION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1923393 GMK-HINGE FIXED TIBIAL INSERT SIZE 5/20MM KNEE REVISION INSERT KRO MEDACTA INTERNATIONAL SA 02.09.0520H 182059 07630030825293

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention