BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 L

    MDR report key: 11087672 · Received December 29, 2020

    Report

    Report Number
    3005180920-2020-00960
    Event Type
    Injury
    Date Received
    December 29, 2020
    Date of Event
    December 2, 2020
    Report Date
    December 29, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825798
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 DECEMBER 2020 LOT 172726: 30 ITEMS MANUFACTURED AND RELEASED ON 3-OCT-2017. EXPIRATION DATE: 2022-09-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 27 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH NO OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.07.1202L TIBIAL TRAY FIXED CEMENTED SIZE 2 L (K090988) LOT. 1903525 BATCH REVIEW PERFORMED ON 14 DECEMBER 2020 LOT 1903525: 67 ITEMS MANUFACTURED AND RELEASED ON 4-OCT-2019. EXPIRATION DATE: 2024-09-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 63 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH NO OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING KNEE PAIN AFTER 5 MONTHS FROM THE PRIMARY SURGERY. POST-OP X-RAYS INDICATED THAT FEMORAL COMPONENT AND TIBIAL TRAY WERE LOOSE. THE REASON FOR THE LOOSE COMPONENTS IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1553319 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 L CEMENTED FEMORAL PROSTHESIS JWH MEDACTA INTERNATIONAL SA 02.12.0002L 172726 07630030825798

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention