BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION 3DMETAL FEMORAL CONE SMALL TRIAL

    MDR report key: 10343416 · Received July 30, 2020

    Report

    Report Number
    3005180920-2020-00479
    Event Type
    Injury
    Date Received
    July 30, 2020
    Date of Event
    July 8, 2020
    Report Date
    July 30, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    UDI-DI
    07630971268029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 20 JULY 2020 LOT 2051540: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAY-2020. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ANY OTHER SIMILAR EVENT HAS BEEN REPORTED. ADDITIONAL INSTRUMENT INVOLVED: GMK HINGE 02.09.10.0054 HINGE TRIAL FEMUR #2 R LOT. 1551733 BATCH REVIEW PERFORMED ON 20 JULY 2020. LOT 1551733: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JAN-2010. EXPIRATION DATE: 2014-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ANY SIMILAR EVENT HAS BEEN REPORTED ON THIS LOT SINCE 2016.

    Description of Event or Problem · 1

    DURING A REVISION SURGERY OF A COMPETITOR KNEE TO A MEDACTA KNEE, THE SURGEON WAS STARTING TO PREP FOR THE FEMORAL CONE,. WHILE PREPPING FOR THE FEMORAL CONE, THE SURGEON PULLED THE HINGE FEMORAL TRIAL OFF AND OBSERVED HE HAD FRACTURED THE DISTAL FEMORAL CONDYLE. THE SURGEON DECIDED NOT TO REVISE THE PATIENT WITH MEDACTA PRODUCTS AND INSTEAD REVISED WITH COMPETITOR PRODUCTS. IT WAS ALSO OBSERVED THAT THE PATIENT HAD VERY POOR BONE QUALITY. THERE WAS A 1 HOUR AND 45 MINUTE DELAY IN THE CASE AND ADDITIONAL ANESTHESIA WAS NECESSARY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE FRACTURE REASON'S IS BONE LOSS AND BONE QUALITY. THE POINT OF FRACTURE IS MEDIAL FEMORAL CONDYLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810571 GMK-REVISION 3DMETAL FEMORAL CONE SMALL TRIAL INSTRUMENT FOR KNEE SURGERY LXH MEDACTA INTERNATIONAL SA 2051540 07630971268029

    Patients

    Seq Age Sex Outcome Treatment
    1 Other