BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L

    MDR report key: 9510768 · Received December 23, 2019

    Report

    Report Number
    3005180920-2019-01091
    Event Type
    Injury
    Date Received
    December 23, 2019
    Date of Event
    December 2, 2019
    Report Date
    December 23, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819865
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 06 DECEMBER 2019 LOT 1902671: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JUL-2019. EXPIRATION DATE: 2024-07-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED IN THE EVENT: GMK-SPHERE 02.12.0022L FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L LOT. 1900302 (K140826) BATCH REVIEW PERFORMED ON 06 DECEMBER 2019 LOT 1900302: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAY-2019. EXPIRATION DATE: 2024-05-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.0210FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L LOT. 1811442 (K121416) BATCH REVIEW PERFORMED ON 06 DECEMBER 2019 LOT 1811442: 120 ITEMS MANUFACTURED AND RELEASED ON 29-MAR-2019. EXPIRATION DATE: 2024-03-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A WASHOUT AND LINER EXCHANGE PERFORMED FOR SUSPECTED INFECTION 2 MONTHS AND 1 WEEK AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1304083 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 1902671 07630030819865

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other