BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/12 MM LEFT

    MDR report key: 6387438 · Received March 8, 2017

    Report

    Report Number
    3005180920-2017-00094
    Event Type
    Malfunction
    Date Received
    March 8, 2017
    Date of Event
    February 6, 2017
    Report Date
    June 22, 2017
    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

    ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2017 AND INCLUDES: THE SURGEON SWAPPED THE POLY AS PLANNED ON (B)(6) 2017. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON 03 MARCH 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: DURING 3 MONTH FOLLOW-UP, RADIOGRAPHIC IMAGES SHOW THE PRESENCE OF A LOOSENED INSERT SCREW. THIS EVENT MAY BE CAUSED BY INSUFFICIENT TIGHTENING TORQUE BUT THE REAL CAUSE CAN'T BE DETERMINED. IMMEDIATE REMOVAL IS STRONGLY RECOMMENDED. IF THE CURRENT SITUATION REMAINED AS REPRESENTED IN THE RADIOGRAPH, NO INVOLVEMENT OF THE ARTICULAR SURFACES MAY HAVE OCCURRED YET, THUS NO NEGATIVE CONSEQUENCES SHOULD BE EXPECTED FOR THE PATIENT AND THE DURATION OF THE IMPLANT, WHICH CAN WORK PROPERLY EVEN IN ABSENCE OF THE SAFETY SCREW. BATCH REVIEW PERFORMED ON 07 MARCH 2017. LOT 153749: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 NOVEMBER 2015. EXPIRATION DATE: 2020-11-01. 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 Manufacturer Narrative · 1

    ON (B)(6) 2017 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE EXPLANTED INSERT FIXATION SCREW, AND COMMENTED AS FOLLOWS: THE INSERT FIXATION SCREW WAS FOUND BACKED OUT AFTER 4 MONTHS FROM PRIMARY SURGERY. THE MOST-LIKELY CAUSE FOR SELF-UNSCREWING OF THE SCREW AFTER FEW MONTHS FROM IMPLANTATION, WAS INSUFFICIENT TIGHTENING TORQUE. THE SCREW LOOKS NOT DAMAGED IN ITS THREADED PART, AND SEEMS TO BE IN COMPLIANCE WITH THE SPECIFICATION REQUIRED. EVEN IF APPARENTLY (ACCORDING TO THE RADIOGRAPHIC IMAGES) THE SCREW WAS NOT FOUND LOOSENED IN THE JOINT, THE SURGEON DECIDED TO SWAP THE POLY AS WELL. IT WAS DEEMED NOT NECESSARY TO REVIEW ANY OTHER COMPONENTS.

    Description of Event or Problem · 1

    THE SURGEON NOTICED THAT THE SCREW HAD BACKED OUT OF THE TIBIAL BASEPLATE OF THE PATIENT LEFT KNEE. THE CAUSE OF THE SCREW BACKING OUT IS UNKNOWN. THE SURGEON PLANS TO SWAP THE POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171671 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/12 MM LEFT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 153749

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention