BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 20732325 · Received November 20, 2024

    Report

    Report Number
    3005180920-2024-00974
    Event Type
    Injury
    Date Received
    November 20, 2024
    Date of Event
    October 24, 2024
    Report Date
    November 20, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819865
    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 11-11-2024. LOT 2313903: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-09-2023. EXPIRATION DATE: 2028-08-22. 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. ADDITIONA IMPLANTS REVISED, BATCH REVIEW PERFORMED ON 11-11-2024. GMK-SPHERE 02.12.0003L GMK-SPHERE FEMORAL COMPONENT CEMENTED - 3L (K121416) LOT 2307454: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-06-2023. EXPIRATION DATE: 2028-06-06. 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 02.12.E0220FL GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 2L - 20MM (K202022) LOT 2243352: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-01-2023. EXPIRATION DATE: 2028-01-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEM OF THE SAME LOT HAS BEEN SOLD. GMK-SPHERE 02.12.E003RP GMK-SPHERE RESURFACING PATELLA E-CROSS - S3 (K202022) LOT 2314690: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-10-2023. EXPIRATION DATE: 2028-09-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEM OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    AT ABOUT 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND IMPLANTED NEW PERMANENT PRODUCTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2430772 GMK PRIMARY TOTAL KNEE SYSTEM FIXED TIBIAL TRAY CEMENTED LEFT, SIZE 2 JWH MEDACTA INTERNATIONAL SA 02.07.1202L 2313903 07630030819865

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention