BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TIBIAL TRAY

    MDR report key: 6762724 · Received August 3, 2017

    Report

    Report Number
    3005180920-2017-00429
    Event Type
    Injury
    Date Received
    August 3, 2017
    Date of Event
    July 5, 2017
    Report Date
    August 3, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030827136
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 26 JULY 2017. LOT 162189: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31 MAY 2016. EXPIRATION DATE: 2021-05-19. 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 TIBIAL INSERT FIXED FLEX #4/10 MM L, CODE 02.12.0410FL LOT. 161684: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01 JUNE 2016. EXPIRATION DATE: 2021-05-18. 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. ON (B)(6) 2017 THE MEDICAL AFFAIRS DIRECTOR MADE THE FOLLOWING ANALYSIS: PARTIAL REVISION OF CEMENTED TKR AFTER 6+ MONTHS. ACCORDING TO REPORT, A PROBLEM OF TIBIAL ROTATION MAY HAVE TRIGGERED PATIENT DISCOMFORT. TIBIAL POSITION CANNOT BE ACCURATELY EVALUATED FROM THE PRE-REVISION XRAY SUPPLIED BECAUSE IT WAS TAKEN IN THE SUPINE POSITION. HOWEVER, THE SURGICAL ACTION DECIDED BY THE VERY EXPERT SURGEON CORROBORATES THE IDEA OF A ROTATED TIBIAL COMPONENT. THE CAUSES THAT LED TO SUCH POSSIBLE TIBIAL ROTATION ARE NOT REPORTED. THERE IS NO INDICATION OF A MALFUNCTIONING DEVICE. THE POST-REVISION XRAY LOOKS PERFECT.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO INSTABILITY ABOUT 9 MONTHS AFTER PRIMARY. THE PATIENT WAS EXPERIENCING TIBIAL PAIN AND DISCOMFORT POSSIBLY DUE TO A MALROTATED TIBIA, THE TIBIAL COMPONENT AND THE INLAY WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544104 GMK SPHERE TIBIAL TRAY FIXED CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 162189 07630030827136

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention