BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L

    MDR report key: 12038957 · Received June 22, 2021

    Report

    Report Number
    3005180920-2021-00526
    Event Type
    Injury
    Date Received
    June 22, 2021
    Date of Event
    May 28, 2021
    Report Date
    June 22, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819865
    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 22 JUNE 2021: LOT 1906237: 119 ITEMS MANUFACTURED AND RELEASED ON 19-NOV-2019. EXPIRATION DATE: 2024-11-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 109 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 22 JUNE 2021: GMK-SPHERE 02.12.0002L FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 (K121416) LOT 1904570: 55 ITEMS MANUFACTURED AND RELEASED ON 12-SEPT-2019. EXPIRATION DATE: 2024-08-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 42 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.0210FL TIBIAL INSERT FIXED SPHERE FLEX #2/10 MM L (K121416) LOT 1906808: 90 ITEMS MANUFACTURED AND RELEASED ON 24-SEPT-2019. EXPIRATION DATE: 2024-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 76 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING INSTABILITY 1 YEAR 4 MONTHS AFTER THE SURGERY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY, AND INSERT WITH COMPETITOR IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935464 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L KNEE CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 02.07.1202L 1906237 07630030819865

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention