BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM L

    MDR report key: 18985055 · Received March 27, 2024

    Report

    Report Number
    3005180920-2024-00185
    Event Type
    Injury
    Date Received
    March 27, 2024
    Date of Event
    March 1, 2024
    Report Date
    March 27, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862526
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 27-MAR-2024: LOT 2201026: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-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 WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON 27-MAR-2024: GMK-SPHERE 02.12.0022L FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L (K140826) LOT 2204931: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAY-2022. EXPIRATION DATE: 2027-05-11. 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. GMK-SPHERE 02.07.1202L TIBIAL TRAY FIXED CEMENTED SIZE 2 L (K090988) LOT 2202592: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUN-2022. EXPIRATION DATE: 2027-05-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 3 MONTHS AFTER PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND INSERTED CEMENT MOLD. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE DELAY TIME WAS 10MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527128 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 2201026 07630030862526

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention