BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L

    MDR report key: 17387762 · Received July 25, 2023

    Report

    Report Number
    3005180920-2023-00566
    Event Type
    Injury
    Date Received
    July 25, 2023
    Date of Event
    June 28, 2023
    Report Date
    July 25, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819865
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17-JUL-2023 LOT 2248784: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-APR-2023. EXPIRATION DATE: 2028-03-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 24 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 17-JUL-2023 GMK-SPHERE 02.12.E0211FL TIBIAL INSERT FIXED SPHERE FLEX #2/11 MM L E-CROSS (K202022) LOT 2243343: 30 ITEMS MANUFACTURED AND RELEASED ON 03-JAN-2023. EXPIRATION DATE: 2027-12-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 10 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    DURING THE PRIMARY KNEE SURGERY, WHEN THE SURGEON WAS IMPLANTING THE INSERT, IT WOULD NOT SEAT. THE SURGEON OPTED TO USE A MALLET AGAINST THE PLASTIC POLY. DURING THIS ATTEMPT TO SET THE POLY WITH THE MALLET, THE TIBIA ROTATED DISTALLY AND WAS KICKED OUT FROM THE KEEL WHICH PUNCTURED THE TIBIA RESULTING IN A TOTAL FRACTURE. THE SURGEON PUT A PLATE WITH NINE SCREWS AS WELL AS A 30 MM EXTENSION STEM FOR THE FRACTURE. THERE WAS A 10-MINUTE DELAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633280 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L KNEE TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 2248784 07630030819865

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Other