BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 6 L

    MDR report key: 10822487 · Received November 11, 2020

    Report

    Report Number
    3005180920-2020-00789
    Event Type
    Injury
    Date Received
    November 11, 2020
    Date of Event
    October 12, 2020
    Report Date
    November 11, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825873
    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 22 OCTOBER 2020: LOT 155735: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-JAN-2016. EXPIRATION DATE: 2020-12-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 20 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 1-1-2016. OTHER DEVICES INVOLVED IN THE EVENT: GMK-SPHERE 02.07.1205L TIBIAL TRAY FIXED CEMENTED SIZE 5 L LOT. 161294 (K090988). BATCH REVIEW PERFORMED ON 22 OCTOBER 2020: LOT 155735: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-APR-2016. EXPIRATION DATE: 2021-03-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.0510FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L LOT. 157022 (K121416). BATCH REVIEW PERFORMED ON 22 OCTOBER 2020: LOT 157022: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-MAR-2016. EXPIRATION DATE: 2021-02-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 47 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 1-1-2016. GMK-SPHERE 02.07.0036RP PATELLA RESURFACING SIZE 4 LOT. 160184 (K113571). BATCH REVIEW PERFORMED ON 22 OCTOBER 2020: LOT 160185: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-MAR-2016. EXPIRATION DATE: 2021-07-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 109 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. 4 YEARS AND 2 MONTHS AFTER PRIMARY THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286323 GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 6 L FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 02.12.0006L 155735 07630030825873

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention