BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ R

    MDR report key: 8762570 · Received July 4, 2019

    Report

    Report Number
    3005180920-2019-00535
    Event Type
    Injury
    Date Received
    July 4, 2019
    Date of Event
    June 4, 2019
    Report Date
    July 4, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862366
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13 JUNE 2019: LOT 183454: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18JUL-2018. EXPIRATION DATE: 2023-07-04. 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 IMPLANTS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 13 JUNE 2019: GMK-SPHERE 02.12.0210FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R (K121416): LOT 176166: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-FEB-2018. EXPIRATION DATE: 2023-02-05. 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. GMK-SPHERE 02.07.1202R TIBIAL TRAY FIXED CEMENTED SIZE 2 R (K090988) LOT. 177229: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-FEB-2018. EXPIRATION DATE: 2023-02-12. 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

    ABOUT 5 MONTHS AND A HALF AFTER PRIMARY THE SURGEON REVISED THE PATIENT KNEE FOR A INFECTION. THE PATIENT HAD A SEPTIC ARTHRITIS. FEMUR, TIBIA AND INSERT REVISED SUCCESSFULLY. THE PATHOGEN IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556295 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ R KNEE FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 183454 07630030862366

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention