BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FEMUR REVISION PS SIZE 5 L

    MDR report key: 15624374 · Received October 18, 2022

    Report

    Report Number
    3005180920-2022-00783
    Event Type
    Injury
    Date Received
    October 18, 2022
    Date of Event
    September 26, 2022
    Report Date
    October 18, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030821448
    PMA / PMN Number
    K102437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 06 OCTOBER 2022: LOT 1903713: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-SEPT-2019. EXPIRATION DATE: 2024-08-28. 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. ADDITIONAL COMPONENTS INVOLVED: GMK-REVISION 02.07.1205L FIXED TIBIAL TRAY CEMENTED SIZE 5 L (K090988) LOT. 2119245: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-MAY-2022. EXPIRATION DATE: 2027-04-21. 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. GMK-REVISION 02.07.0517SCF FIXED TIBIAL INSERT SC SIZE 5/17MM (K103170) LOT. 176796: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-DEC-2017. EXPIRATION DATE: 2022-11-21. 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. ON (B)(6) 2022, THE PATIENT WENT HOME AFTER THE PRIMARY KNEE SURGERY. WHILE AT HOME, THE KNEE FELT LOOSE AND THE FEMUR TRANSLATED ANTERIORLY, DISLOCATING THE KNEE. WHEN THE DOCTOR ANALYZED THE PATIENT, IT WAS OBSERVED THAT ALL OF THE IMPLANTS ARE STILL IN PLACE AND HAVE NOT DISLOCATED. THE SURGEON DECIDED TO REVISE THE FEMUR TO A REVISION FEMUR AND REVISE THE INSERT WITH A SC INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN SHOWING SIGNS OF INSTABILITY AND DISLOCATION DUE TO A COMPROMISED MCL. THE SURGEON DECIDED TO REMOVE ALL IMPLANTS AND TO IMPLANT A HINGE KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2351739 GMK-REVISION FEMUR REVISION PS SIZE 5 L KNEE REVISION FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.07.2405L 1903713 07630030821448

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention