BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L

    MDR report key: 18510520 · Received January 15, 2024

    Report

    Report Number
    3005180920-2023-01106
    Event Type
    Injury
    Date Received
    January 15, 2024
    Date of Event
    December 21, 2023
    Report Date
    January 15, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819889
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28-DEC-2023, LOT 2210918: 24 ITEMS MANUFACTURED AND RELEASED ON 21-SEP-2022. EXPIRATION DATE: 2027-09-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 23 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 28-DEC-2023. GMK-SPHERE 02.12.0023L FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ L (K140826) LOT. 2215962. LOT 2215962: 36 ITEMS MANUFACTURED AND RELEASED ON 19-OCT-2022. EXPIRATION DATE: 2027-10-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 32 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0314FL TIBIAL INSERT FIXED SPHERE FLEX #3/14 MM L (K121416) LOT. 187216, LOT 187216: 30 ITEMS MANUFACTURED AND RELEASED ON 03-JAN-19. EXPIRATION DATE: 2023-12-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 19 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 10 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO REVISION COMPONENTS AND THE SURGERY COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644650 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 2210918 07630030819889

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention