BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L

    MDR report key: 8428914 · Received March 18, 2019

    Report

    Report Number
    3005180920-2019-00166
    Event Type
    Injury
    Date Received
    March 18, 2019
    Date of Event
    February 18, 2019
    Report Date
    March 18, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862397
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 MARCH 2019: LOT 165985: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-NOV-2016. EXPIRATION DATE: 2021-11-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED, NOT AVAILABLE FOR FURTHER INVESTIGATION: GMK-SPHERE 02.12.0410FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L (K121416), LOT. 141017:50 ITEMS MANUFACTURED AND RELEASED ON 10-APR-2014. EXPIRATION DATE: 2019-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION ABOUT 2 YEARS AFTER PRIMARY, THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FEMORAL COMPONENT AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222236 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L CEMENTED FEMORAL KNEE JWH MEDACTA INTERNATIONAL SA 165985 07630030862397

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention