BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERIKA FEMORAL COMPONENT SPHERIKA CEMENTED S3+L

    MDR report key: 20046119 · Received August 23, 2024

    Report

    Report Number
    3005180920-2024-00638
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    July 26, 2024
    Report Date
    August 23, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630345716217
    PMA / PMN Number
    K211004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 02-AUG-2024. LOT 2346852: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-APR-2024. EXPIRATION DATE: 2029-04-02. 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. OTHER DEVICES INVOLVED: GMK-SPHERIKA 02.12.E0313FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/13 MM L E-CROSS (K202022) LOT 2238817: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-NOV-2022. EXPIRATION DATE: 2027-10-17. 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-SPHERIKA 02.12.E002RP PATELLA RESURFACING SIZE 2 E-CROSS (K202022) LOT 2346255: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-FEB-2024. EXPIRATION DATE: 2029-01-23. 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-SPHERIKA 02.07.1203L TIBIAL TRAY FIXED CEMENTED SIZE 3 L (K090988) LOT 2345288: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-MAR-2024. EXPIRATION DATE: 2029-03-07. 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.

    Description of Event or Problem · 0

    AT ABOUT 2 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO GMK-HINGE COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364093 GMK-SPHERIKA FEMORAL COMPONENT SPHERIKA CEMENTED S3+L KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 2346852 07630345716217

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention