BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM L

    MDR report key: 16583372 · Received March 21, 2023

    Report

    Report Number
    3005180920-2023-00162
    Event Type
    Injury
    Date Received
    March 21, 2023
    Date of Event
    February 20, 2023
    Report Date
    March 21, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862601
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 27 FEBRUARY 2023: LOT 1906085: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-SEPT-2019. EXPIRATION DATE: 2024-08-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDITIONAL COMPONENTS INVOVLED: GMK-SPHERE 02.07.1204L TIBIAL TRAY FIXED CEMENTED SIZE 4 L (K090988) LOT. 2203733: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUN-2022. EXPIRATION DATE: 2027-06-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0004L FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L (K121416) LOT. 2204899: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-MAY-2022. EXPIRATION DATE: 2027-05-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. GMK-SPHERE 02.07.0034RP PATELLA RESURFACING SIZE 2 (K090988) LOT. 2216929: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-OCT-2022. EXPIRATION DATE: 2027-09-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 1 MONTH FROM PRIMARY THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24952 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0411FL 1906085 07630030862601

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention