BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3 R

    MDR report key: 10194001 · Received June 25, 2020

    Report

    Report Number
    3005180920-2020-00364
    Event Type
    Injury
    Date Received
    June 25, 2020
    Date of Event
    May 29, 2020
    Report Date
    June 25, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825828
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 23-JUN-2020: LOT 187144: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-OCT-2018. EXPIRATION DATE: 11-OCT-2023. 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 DEVICE INVOLVED IN THE EVENT: GMK-SPHERE 02.12.0314FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/14 MM R LOT. 1811491 (K121416). BATCH REVIEW PERFORMED ON 23-JUN-2020: LOT 1811491: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-APR-2019. EXPIRATION DATE: 23-MAR-2024. 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 DUE TO SIGNS OF INFECTION 6 MONTHS AFTER THE PRIMARY, THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND REVISED THE FEMORAL COMPONENT AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658724 GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3 R CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0003R 187144 07630030825828

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention