BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R

    MDR report key: 10604907 · Received September 30, 2020

    Report

    Report Number
    3005180920-2020-00652
    Event Type
    Injury
    Date Received
    September 30, 2020
    Date of Event
    August 31, 2020
    Report Date
    September 30, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825828
    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 BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON (B)(6) 2020: LOT 184850: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-SEP-2018. EXPIRATION DATE: 2023-09-03. 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. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 10.09.2020: GMK-SPHERE 02.07.1203R TIBIAL TRAY FIXED CEMENTED SIZE 3 R (K090988) LOT. 182902 LOT 182902: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2018. EXPIRATION DATE: 2023-09-02. 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 · 1

    THE PATIENT CAME IN REPORTING PAIN DUE TO AN ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS 1 YEAR AND 7 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON REMOVED ALL IMPLANTS AND REVISED THEM WITH COMPETITOR PRODUCTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071105 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0003R 184850 07630030825828

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention