BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-HINGE GMK-HINGE FEMORAL COMPONENT R - SIZE 5

    MDR report key: 10331333 · Received July 28, 2020

    Report

    Report Number
    3005180920-2020-00471
    Event Type
    Injury
    Date Received
    July 28, 2020
    Date of Event
    July 6, 2020
    Report Date
    July 28, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825484
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15 JULY 2020: LOT 173971: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-NOV-2017. EXPIRATION DATE: 2022-09-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-HINGE 02.09.0514H FIXED TIBIAL INSERT SIZE 5/14MM (K130299) LOT. 135352. BATCH REVIEW PERFORMED ON 15 JULY 2020: LOT 135352: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-FEB-2014. EXPIRATION DATE: 2018-12-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 1-1-2016.

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2017. ON (B)(6) 2018, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON REVISED ALL HARDWARE AND IMPLANTED A SPACER. PRESENTLY, ON (B)(6) 2020 (2 YEARS AND 8 MONTHS AFTER PRIMARY), THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS PSEUDOMONAS. THE SURGEON PLANNED TO PERFORM A POLY-SWAP, BUT NOTICED DURING SURGERY THAT THE FEMORAL COMPONENT WAS LOOSE. THE SURGEON PERFORMED A POLY-SWAP AND EXTRACTED AND REPLACED WITH A HINGE FEMORAL COMPONENT WITH A STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798322 GMK-HINGE GMK-HINGE FEMORAL COMPONENT R - SIZE 5 CEMENTED FEMORAL COMPONENT KRO MEDACTA INTERNATIONAL SA 02.09.2605R 173971 07630030825484

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention