BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ L

    MDR report key: 18301128 · Received December 11, 2023

    Report

    Report Number
    3005180920-2023-00963
    Event Type
    Injury
    Date Received
    December 11, 2023
    Date of Event
    November 17, 2023
    Report Date
    December 11, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862373
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20 NOVEMBER 2023: LOT 2004468: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-AUG-2020. EXPIRATION DATE: 2025-07-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 51 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED BATCH REVIEW PERFORMED ON 20 NOVEMBER 2023: GMK-SPHERE 02.12.0311CRL TIBIAL INSERT FIXED SPHERE CR SIZE 3/11 MM L (K181635) LOT 1902516: 30 ITEMS MANUFACTURED AND RELEASED ON 18-JUNE-2019. EXPIRATION DATE: 2024-06-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW GMK-SPHERE 02.07.1203L TIBIAL TRAY FIXED CEMENTED SIZE 3 L (K090988) LOT 2002926: 85 ITEMS MANUFACTURED AND RELEASED ON 20-JULY-2020. EXPIRATION DATE: 2025-07-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.07.0034RP PATELLA RESURFACING SIZE 2 (K090988) LOT 2006033: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JULY-2020. EXPIRATION DATE: 2025-07-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) 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 2 YEARS 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND KNEE PAIN DUE TO A LOOSE PATELLA IMPLANT, FEMORAL COMPONENT AND TIBIAL TRAY. THE SURGEON REVISED THE PATELLA IMPLANT, FEMORAL COMPONENT, INSERT AND TIBIAL TRAY. THE INSERT WAS INCREASED FROM AN 11MM TO A 14MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1845709 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ L KNEE CEMENTED FEMUR JWH MEDACTA INTERNATIONAL SA 2004468 07630030862373

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention