BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L

    MDR report key: 9233160 · Received October 24, 2019

    Report

    Report Number
    3005180920-2019-00905
    Event Type
    Injury
    Date Received
    October 24, 2019
    Date of Event
    September 27, 2019
    Report Date
    October 24, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030827136
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 OCTOBER 2019: LOT 181873: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JUN-2018. EXPIRATION DATE: 2023-06-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED IN THE EVENT: GMK-SPHERE 02.12.0004L FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L LOT. 180950 (K121416). BATCH REVIEW PERFORMED ON 09 OCTOBER 2019: LOT 180950: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2018. EXPIRATION DATE: 2023-05-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.0410FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L LOT. 180393 (K121416) LOT 180393: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-APR-2018. EXPIRATION DATE: 2023-03-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF ANTERIOR KNEE PAIN. THE CAUSE OF THE PAIN IS UNKNOWN. ABOUT 1 YEAR AFTER PRIMARY THE SURGEON RESURFACED THE PATELLA BONE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027886 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 181873 07630030827136

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention