BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L

    MDR report key: 16635897 · Received March 29, 2023

    Report

    Report Number
    3005180920-2023-00195
    Event Type
    Injury
    Date Received
    March 29, 2023
    Date of Event
    March 1, 2023
    Report Date
    March 29, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826139
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 08 MARCH 2023, LOT 1810370: (B)(4) MANUFACTURED AND RELEASED ON 14-MARCH-2019. EXPIRATION DATE: 2024-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL INVOLVED IMPLANT BATCH REVIEW PERFORMED ON 08 MARCH 2023 ON GMK-SPHERE 02.07.1202L TIBIAL TRAY FIXED CEMENTED SIZE 2 L (K090988) LOT. 1810451 LOT 1810451: (B)(4) MANUFACTURED AND RELEASED ON 21-MARCH-2019. EXPIRATION DATE: 2024-03-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 3 YEARS 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING LIMITED RANGE OF MOTION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1766617 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L KNEE TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0210FL 1810370 07630030826139

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention