BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3+ R

    MDR report key: 9880470 · Received March 25, 2020

    Report

    Report Number
    3005180920-2020-00177
    Event Type
    Injury
    Date Received
    March 25, 2020
    Date of Event
    February 24, 2020
    Report Date
    March 25, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862380
    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 05 MARCH 2020: LOT 1810113: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-FEB-2019. EXPIRATION DATE: 2024-01-23. 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 DEVICES INVOLVED BATCH REVIEWS PERFORMED ON 05 MARCH 2020: GMK-SPHERE 02.12.0210FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R (K121416) LOT 186055: (B)(4)ITEMS MANUFACTURED AND RELEASED ON 29-NOV-2018. EXPIRATION DATE: 2023-11-19. 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 171148: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JUNE-2017. EXPIRATION DATE: 2022-06-12. 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

    THE PATIENT CAME IN REPORTING STIFFNESS AND PAIN IN THE KNEE. THE CAUSE OF THE KNEE STIFFNESS AND PAIN IS PATELLA BAJA. 7 MONTHS AFTER PRIMARY SURGERY THE SURGEON REVISED SUCCESSFULLY THE KNEE SWAPPING THE FEMORAL AND TIBIAL COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344483 GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3+ R KNEE CEMENTED FEMUR JWH MEDACTA INTERNATIONAL SA 02.12.0023R 1810113 07630030862380

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention