BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.12.0312FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM L

    MDR report key: 14051922 · Received April 8, 2022

    Report

    Report Number
    3005180920-2022-00240
    Event Type
    Injury
    Date Received
    April 8, 2022
    Date of Event
    March 9, 2022
    Report Date
    April 8, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826375
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 10 MARCH 2022. LOT 1910683: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JAN-2020. EXPIRATION DATE: 2025-01-06. 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: BATCH REVIEW PERFORMED ON 10 MARCH 2022. GMK-SPHERE 02.12.0023L FEMORAL COMPONENT SPHERE CEMENTED # 3+ L (K140826) LOT 2000502: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-APR-2020. EXPIRATION DATE: 2025-04-14. 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 02.07.0034RP PATELLA RESURFACING # 2 (K090988) LOT 2000629: (B)(4) TEMS MANUFACTURED AND RELEASED ON 12-MAR-2020. EXPIRATION DATE: 2025-02-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE 02.07.1203L TIBIAL TRAY FIXED CEMENTED # 3 L (K090988) LOT 1908619: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-APR-2020. EXPIRATION DATE: 2025-03-26. 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 · 0

    THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO COMPETITOR COMPONENTS ALMOST 1 YEAR AND 7 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160443 GMK-SPHERE 02.12.0312FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM L TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0312FL 1910683 07630030826375

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention