BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R

    MDR report key: 19642078 · Received July 1, 2024

    Report

    Report Number
    3005180920-2024-00513
    Event Type
    Injury
    Date Received
    July 1, 2024
    Date of Event
    June 10, 2024
    Report Date
    July 1, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819933
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 21 JUNE 2024: LOT 170447: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-APR-2017. EXPIRATION DATE: 2022-04-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 21 JUNE 2024 GMK-SPHERE 02.12.0005R FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R (K121416) LOT 173642: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-NOV-2017. EXPIRATION DATE: 2022-11-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0510FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R (K121416) LOT 171901: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JUNE-2017. EXPIRATION DATE: 2022-06-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) 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 6 YEARS 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS EXCEPT THE PATELLA TO REVISION COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2184911 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R KNEE TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 170447 07630030819933

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention