BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE PATELLA RESURFACING SIZE 1

    MDR report key: 11551131 · Received March 23, 2021

    Report

    Report Number
    3005180920-2021-00233
    Event Type
    Injury
    Date Received
    March 23, 2021
    Date of Event
    February 25, 2021
    Report Date
    March 23, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030815737
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 04 MARCH 2021: LOT 1901655: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MAY-2019. EXPIRATION DATE: 2024-04-21. 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. ADDITIONAL DEVICE INVOLVED: BATCH REVIEWS PERFORMED ON 04 MARCH 2021: GMK-SPHERE 02.12.0002R FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 R (K121416) LOT 188959: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JAN-2019. EXPIRATION DATE: 2023-12-18. 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 02.07.1202R TIBIAL TRAY FIXED CEMENTED SIZE 2 R (K090988) LOT 1901597: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUL-2019. EXPIRATION DATE: 2024-07-03. 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 02.12.0210FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R (K121416) LOT 1901312: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-JUN-2019. EXPIRATION DATE: 2024-05-19. 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 PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REMOVED ALL THE IMPLANTS, REVISED THEM WITH NEW IMPLANTS, AND ADDED EXTENSION STEMS, OFFSET CONNECTORS AND A TIBIAL CONE 1 YEAR AND 5 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451719 GMK-SPHERE PATELLA RESURFACING SIZE 1 KNEE PATELLA IMPLANT JWH MEDACTA INTERNATIONAL SA 02.07.0033RP 1901655 07630030815737

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention