BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM LEFT

    MDR report key: 5446937 · Received February 19, 2016

    Report

    Report Number
    3005180920-2016-00053
    Event Type
    Malfunction
    Date Received
    February 19, 2016
    Date of Event
    January 22, 2016
    Report Date
    June 16, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 16 FEBRUARY 2016: LOT 148380: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 JUNE 2015. EXPIRATION DATE: 2020-05-31. 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. BATCH REVIEW ON THE ASSOCIATED TIBIAL BASEPLATE (IMPLANTED) PERFORMED ON 19 FEBRUARY 2016: CODE 02.07.1204L , LOT 136145 (K090988): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 MARCH 2014. EXPIRATION DATE: 2019-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. NOT YET RECEIVED.

    Additional Manufacturer Narrative · 1

    ON 15 JUNE 2016 THE (B)(4) PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED INSERT AND COMMENTED AS FOLLOWS: THE POSTERIOR "CLIPPING" FEATURES OF THE INSERT HAVE BEEN PLASTICALLY DEFORMED AND DAMAGED IN BOTH THE MEDIAL AND THE LATERAL SIDE. THEY PRESENT A SORT OF INCISION WITH THE NEGATIVE SHAPE OF THE CLIPPING "TEETH" OF THE BASEPLATE. WE CAN SUPPOSE THAT PROBABLY, IN THE FIRST ATTEMPT TO FIX THE INSERT INTO THE BASEPLATE, THE INSERT WAS NOT POSTERIORLY WELL POSITIONED. IN THIS ATTEMPT THE INSERT WAS PUSHED POSTERIORLY AND WAS PERMANENTLY DAMAGED WITHOUT POSSIBILITY TO BE CLIPPED IN THE FOLLOWING ATTEMPTS. WE CAN STATE THAT THE EVENT IS NOT IMPLANT RELATED.

    Description of Event or Problem · 1

    DURING A SPHERE KNEE SURGERY THE SURGEON COULD NOT GET THE INSERT TO ENGAGE WITH THE TIBIAL BASEPLATE. THE SURGEON REQUESTED A NEW INSERT. THE NEW INSERT ENGAGED IMMEDIATELY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE IMPLANT WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104895 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM LEFT FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 148380

    Patients

    Seq Age Sex Outcome Treatment
    1 Other