BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L

    MDR report key: 11372688 · Received February 24, 2021

    Report

    Report Number
    3005180920-2021-00141
    Event Type
    Injury
    Date Received
    February 24, 2021
    Date of Event
    January 26, 2021
    Report Date
    February 24, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819902
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 5 FEBRUARY 2021: LOT 1904222: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 6-NOV-2019. EXPIRATION DATE: 2024-10-26. 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. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 5 FEBRUARY 2021: GMK-SPHERE 02.12.0005L FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L (K121416) LOT. 1904576 LOT 1904576: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 5-SEP-2019. EXPIRATION DATE: 2024-08-20. 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. THE CERTIFICATE OF THE MATERIAL COMPOSITION HAS BEEN VERIFIED. ACCORDING TO THIS CERTIFICATE, THE MATERIAL IS CONFORMING TO THE SPECIFICATION.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY(PROBABLY CAUSED BY ALLERGY) 10 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON PERFORMED AN ALLERGY TEST ON THE PATIENT AND IT WAS OBSERVED THAT THE PATIENT WAS ALLERGIC TO NICKEL. THE SURGEON REVISED ALL THE COMPONENTS EXCEPT THE PATELLA WITH COMPETITOR HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON WAS NOT AWARE THAT THE PATIENT WAS ALLERGIC TO NICKEL DURING THE PRIMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271387 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.1204L 1904222 07630030819902

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention