BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FEMUR REVISION PS SIZE 3 L

    MDR report key: 10366570 · Received August 5, 2020

    Report

    Report Number
    3005180920-2020-00511
    Event Type
    Injury
    Date Received
    August 5, 2020
    Date of Event
    July 13, 2020
    Report Date
    August 5, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030821400
    PMA / PMN Number
    K102437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 24 JULY 2020: LOT 1900618: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-05-2019. EXPIRATION DATE: 2024-05-13, NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICE INVOLVED IN THE EVENT: GMK-REVISION 02.07.10.0858 TRIAL TIBIAL INSERT SC FIXED #2 - 10 MM LOT. 1410625. BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 24 JULY 2020: LOT 1410625: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-06-2014. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED SINCE 2016.

    Description of Event or Problem · 1

    DURING THE PRIMARY KNEE SURGERY, WHILE THE SURGEON WAS TRIALING THE SC TRIAL INSERT WITH THE FINAL FEMORAL AND TIBIAL IMPLANTS, THE TRIAL INSERT WOULD NOT LOCK INTO THE FINAL TIBIAL BASEPLATE. DURING THIS TRIAL RANGE OF MOTION A FRACTURE OF THE MEDIAL DISTAL FEMORAL CONDYLE WAS NOTICED. THE SURGEON CABLED THE FRACTURE TO STABILIZE THE COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON WAS ABLE TO INSERT THE FINAL IMPLANT POLY INSERT INTO THE BASEPLATE. THE FRACTURE MAY HAVE DEVELOPED WHEN IMPACTING THE FEMORAL IMPLANT COMPONENT. FURTHER, THE BONE WAS OF VERY POOR QUALITY AND WAS DEFICIENT IN MUCH OF THE DISTAL FEMUR. WE ALSO USED A FEMORAL CONE AUGMENT TO TRY TO REINFORCE THE DISTAL FEMUR WHICH REQUIRED FURTHER REMOVAL OF SOME REMAINING CANCELLOUS DISTAL BONE. THE MEDIAL DISTAL FEMORAL CONDYLE DIDN'T PARTIALLY DISPLACE HOWEVER UNTIL WE WERE DOING A TRIAL RANGE OF MOTION WITH THE TRIAL INSERT PAIRED WITH THE FINAL IMPLANT FEMORAL AND TIBIAL COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833103 GMK-REVISION FEMUR REVISION PS SIZE 3 L FEMUR REVISION JWH MEDACTA INTERNATIONAL SA 02.07.2403L 1900618 07630030821400

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention