BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L

    MDR report key: 19381857 · Received May 23, 2024

    Report

    Report Number
    3005180920-2024-00347
    Event Type
    Injury
    Date Received
    May 23, 2024
    Date of Event
    April 22, 2024
    Report Date
    May 23, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030827136
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 6 MAY 2024. LOT 2204684: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JUL-2022. EXPIRATION DATE: 2027-JUN-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT ONE YEAR AFTER PRIMARY CEMENTED TKA, AT REVISION SURGERY, IT IS FOUND THAT THE CEMENT DID NOT ADHERE TO THE METAL IMPLANTS. THIS CAN BE DUE TO A NUMBER OF DIFFERENT FACTORS: THE MOST INFLUENTIAL ONES ARE TIMING OF APPLICATION OF THE CEMENT TO THE COMPONENTS AND POSSIBLE TRACES OS MOISTURE ON THE METAL SURFACES, BUT OTHER FACTORS MAY ALSO PLAY A ROLE, SUCH AS ROOM TEMPERATURE, OR STORAGE TEMPERATURE OF THE CEMENT. THERE IS NO REASON TO SUSPECT A DEFECTIVE DEVICE AT THE ORIGIN OF THIS PROBLEM. ADDITIONAL IMPLANTS REVISED. BATCH REVIEW PERFORMED ON 6 MAY 2024 ON GMK-SPHERE 02.12.0024L FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L (K140826) LOT. 2211881 LOT 2211881: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-SEP-2022. EXPIRATION DATE: 2027-AUG-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 6 MAY 2024 ON GMK-SPHERE 02.12.0410FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L (K121416) LOT. 2112454. LOT 2112454: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-OCT-2021. EXPIRATION DATE: 2026-SEP-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED DUE TO PAIN PERFORMED ABOUT 1 YEAR AND 2 MONTHS AFTER THE PRIMARY SURGERY. DURING THE REVISION, IT WAS NOTED THAT THE CEMENT HAD NOT ADHERED TO THE FEMORAL AND TIBIAL COMPONENTS (CEMENT WAS NOT MEDACTA). ALL COMPONENTS REVISED TO GMK REVISION SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219861 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L KNEE CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 2204684 07630030827136

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention