BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R

    MDR report key: 9097723 · Received September 20, 2019

    Report

    Report Number
    3005180920-2019-00786
    Event Type
    Injury
    Date Received
    September 20, 2019
    Date of Event
    August 22, 2019
    Report Date
    September 20, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825842
    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 ON 03.SEP.2019: LOT 151997: 41 ITEMS MANUFACTURED AND RELEASED ON 11-JUN-2015. EXPIRATION DATE: 30/04/2020. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL 41 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED. BATCH REVIEWS PERFORMED ON 03.SEP.2019: GMK-SPHERE 02.12.T3I4R TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R (K121416) LOT 153119: 49 ITEMS MANUFACTURED AND RELEASED ON 11-JUN-2015. EXPIRATION DATE: 30/04/2020. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE 49 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.0410FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM (K121416) LOT 148390: 50 ITEMS MANUFACTURED AND RELEASED ON 20 AUGUST 2015. EXPIRATION DATE: 2020-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE 50 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF LIMITED RANGE OF MOTION AFTER ABOUT 4 YEARS. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY AND POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891329 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R KNEE CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 151997 07630030825842

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention