BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L

    MDR report key: 17868423 · Received October 4, 2023

    Report

    Report Number
    3005180920-2023-00751
    Event Type
    Malfunction
    Date Received
    October 4, 2023
    Date of Event
    September 4, 2023
    Report Date
    November 10, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826610
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED: - PIECE RETURNED ON THE 13TH OF OCTOBER 2023 - VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: THE INSERT LOOKS DAMAGED IN ITS POSTERIOR FEATURE INTENDED TO BE ENGAGED IN THE DEDICATED SEAT OF THE BASEPLATE ON THE MEDIAL SIDE. IT PRESENTS A SORT OF INCISIONS OF THE NEGATIVE SHAPE OF THE PERIPHERAL EDGE OF THE BASEPLATE ALSO THE BOTTOM SURFACE OF THE INSERT PRESENTS LOT OF DENTS IN THE POSTERO-MEDIAL PART. WE GUESS THAT, IN THE FIRST ATTEMPTS TO FIX THE INSERT INTO THE BASEPLATE, THE INSERT WAS NOT WELL POSITIONED AND NOT PROPERLY SEATED INTO THE TIBIAL TRAY. IN THIS ATTEMPT THE INSERT WAS DAMAGED PRECLUDING THE POSSIBILITY TO FIX THE INSERT IN THE FOLLOWING ATTEMPTS. FROM VISUAL INSPECTION, THERE IS NO EVIDENCE THAT THE EVENT IS RELATED TO A FAULTY DEVICE. CORRECTIONS: - B1 FIELD: INSERTION OF "PRODUCT PROBLEM", PREVIOUSLY IT WAS REPORTED "ADVERSE EVENT" - B2 FIELD: INSERTION OF "OTHER SERIOUS OR IMPORTANT MEDICAL EVENTS" , PREVIOUSLY IT WAS REPORTED "REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE" - H1 FIELD: INSERTION OF "MALFUNCTION" AND NOT "SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11 SEPTEMBER 2023: LOT 1910172: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JAN-2020. EXPIRATION DATE: 2024-12-10. 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 INVOLVED PRODUCT: BATCH REVIEW PERFORMED ON 04 OCTOBER 2023 ON GMK-SPHERE 02.07.1204L TIBIAL TRAY FIXED CEMENTED SIZE 4 L (K090988) LOT. 2116001. LOT 2116001: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-APR-2022. EXPIRATION DATE: 2027-03-24. 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

    DURING REVISION SURGERY, THE SURGEON PERFORMED 14MM INSERT TRIAL AND ATTEMPTED TO INSERT A 14MM INSERT, BUT IT WOULD NOT FIT. A 13MM INSERT WAS USED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE DELAY TIME IS 50MIN AND THE TOTAL SURGERY TIME IS 2HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105138 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L KNEE TIBIAL INSERT FLEX JWH MEDACTA INTERNATIONAL SA 1910172 07630030826610

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Other| R