BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERIKA GMK SPHERIKA FEMORAL COMPONENT S3+L CEMENTED

    MDR report key: 18524338 · Received January 17, 2024

    Report

    Report Number
    3005180920-2023-01097
    Event Type
    Injury
    Date Received
    January 17, 2024
    Date of Event
    December 28, 2023
    Report Date
    January 17, 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 16-JAN-2024: LOT 2303087: 35 ITEMS MANUFACTURED AND RELEASED ON 27-APR-2023. EXPIRATION DATE: 2028-04-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 23 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED. BATCH REVIEWS PERFORMED ON 16-JAN-2024: GMK-SPHERIKA 02.12.T4I3L GMK-SPHERE TIBIAL COMPONENT CEMENTED T4I3L (K121416) LOT 2012087: 57 ITEMS MANUFACTURED AND RELEASED ON 12-APR-2021. EXPIRATION DATE: 2026-03-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 46 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERIKA 02.12.T4I3L GMK-SPHERE TIBIAL COMPONENT CEMENTED T4I3L (K121416) LOT 2012087: 57 ITEMS MANUFACTURED AND RELEASED ON 12-APR-2021. EXPIRATION DATE: 2026-03-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 46 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERIKA 02.12.E003RP GMK-SPHERE RESURFACING PATELLA E-CROSS - S3 (K202022) LOT 2311197: 110 ITEMS MANUFACTURED AND RELEASED ON 05-SEP-2023. EXPIRATION DATE: 2028-08-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 70 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    A DAY AFTER THE PRIMARY KNEE SURGERY, THE PATIENT REPORTED INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON DECIDED TO REVISE THE PATIENT TO GMK-HINGE COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1693313 GMK-SPHERIKA GMK SPHERIKA FEMORAL COMPONENT S3+L CEMENTED KNEE CEMENTED FEMUR JWH MEDACTA INTERNATIONAL SA 2303087 07630345716217

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention