BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R

    MDR report key: 11138888 · Received January 8, 2021

    Report

    Report Number
    3005180920-2021-00024
    Event Type
    Injury
    Date Received
    January 8, 2021
    Date of Event
    December 11, 2020
    Report Date
    January 8, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819933
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 21 DECEMBER 2020: LOT 1908644: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAR-2020. EXPIRATION DATE: 2025-02-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 21 DECEMBER 2020: GMK-SPHERE 02.07.0035RP PATELLA RESURFACING SIZE 3 (K090988)LOT. 1908305. LOT 1908305: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-OCT-2019. EXPIRATION DATE: 2024-10-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. BATCH REVIEW PERFORMED ON 21 DECEMBER 2020: GMK-SPHERE 02.12.0511CRR TIBIAL INSERT FIXED SPHERE CR SIZE 5/11 MM R (K181635)LOT. 188617. LOT 188617: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-FEB-2019. EXPIRATION DATE: 2024-02-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. BATCH REVIEW PERFORMED ON 21 DECEMBER 2020: GMK-SPHERE 02.12.0026R FEMORAL COMPONENT SPHERE CEMENTED SIZE 6+ R (K140826)LOT. 190189. LOT 1901899: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JUL-2019. EXPIRATION DATE: 2024-06-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN AND AN INABILITY TO ACHIEVE FULL EXTENSION DUE TO A LOOSE PATELLA, WHICH WAS CAUSED BY A CAR ACCIDENT. PRIOR TO THE REVISION SURGERY, THE PATIENT DEVELOPED AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER 4 MONTHS AFTER THE PRIMARY SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39760 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.1205R 1908644 07630030819933

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention