BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L

    MDR report key: 16960187 · Received May 19, 2023

    Report

    Report Number
    3005180920-2023-00348
    Event Type
    Injury
    Date Received
    May 19, 2023
    Date of Event
    April 20, 2023
    Report Date
    May 19, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826139
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 21 APRIL 2023. LOT 2005719: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-AUG-2020. EXPIRATION DATE: 2025-07-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: REVISION SURGERY OF A GMK SPHERE IMPLANT AFTER 10 MONTHS FROM PRIMARY IMPLANTATION DUE TO DISCOMFORT AND FLEXION CONTRACTURE. IN THE REVISION SURGERY, THE TIBIAL INSERT AND THE TIBIAL TRAY HAVE BEEN REPLACED. A PICTURE OF THE EXPLANTED LINER HAS BEEN SENT FOR INVESTIGATION. FROM THIS PICTURE, WE CAN'T IDENTIFY ANY ANOMALIES OR ELEMENTS THAT CAN BE CONSIDERED RELEVANT FOR THE EVENT. THERE IS NO EVIDENCE THAT THE EVENT IS RELATED TO A FAULTY DEVICE. ADDITIONAL INVOLVED IMPLANT. BATCH REVIEW PERFORMED ON 21 APRIL 2023 ON GMK-SPHERE 02.07.2802L TIBIAL TRAY FIXED CEMENTED SIZE 2 L TINBN COATED (K202684) LOT. 2007330 LOT 2007330: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JAN-2021. EXPIRATION DATE: 2026-01-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING DISCOMFORT DUE TO A FLEXION CONTRACTURE AND THE CAUSE OF THE FLEXION CONTRACTURE IS UNKNOWN. THE SURGEON REVISED THE INSERT AND TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463893 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L KNEE TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0210FL 2005719 07630030826139

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention