BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TIBIAL INSERT

    MDR report key: 6760053 · Received August 2, 2017

    Report

    Report Number
    3005180920-2017-00423
    Event Type
    Injury
    Date Received
    August 2, 2017
    Date of Event
    June 30, 2017
    Report Date
    September 13, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825941
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 08 SEPTEMBER 2017 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE EXPLANTED INSERT FIXATION SCREW AND COMMENTED AS FOLLOWS: LOOSENED INSERT SAFETY SCREW OCCURRED EIGHT MONTHS AFTER PRIMARY SURGERY REMOVED BY ARTHROSCOPY. THE THREADED PART AND THE SCREW LOOKS DAMAGED. THE SCREW HAS BEEN PLASTICALLY DEFORMED ONCE, BACKED OUT FROM THE BASEPLATE, WAS INTERPOSED BETWEEN THE FEMORAL COMPONENT AND THE TIBIA INSERT AND UNDERWENT TO THE BODY LOAD. NO OTHER COMPONENTS HAVE BEEN EXPLANTED. THE MOST-LIKELY CAUSE FOR SELF-UNSCREWING OF THE SCREW AFTER FEW MONTHS FROM IMPLANTATION, WAS INSUFFICIENT TIGHTENING TORQUE. USING A SCREWDRIVER PROVIDED WITH A TORQUE LIMITATION WOULD PREVENT THIS EVENT. TORQUE LIMITER SCREWDRIVER IS ALREADY AVAILABLE AND ITS USE IS MANDATORY.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 26 JULY 2017. LOT 142847: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 JUNE 2014. EXPIRATION DATE: 2019-04-30. 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 28 JULY 2017 THE MEDICAL AFFAIRS DIRECTOR CHECKED THE X-RAY COMMENTING AS FOLLOWING: 7 MONTHS AFTER PRIMARY TKR THE INSERT FIXATION SCREW GOT LOOSE IN THE JOINT. IT WAS IMMEDIATELY REMOVED WITH AN ARTHROSCOPIC OPERATION. NO CONSEQUENCE SHOULD BE EXPECTED FOR THE ABSENCE OF THE SCREW IN THE FUTURE LIFE OF THE IMPLANT. ACCORDING TO REPORT, THERE IS MINIMUM DAMAGE TO THE FEMORAL COMPONENT SURFACE, IN AN AREA OF MARGINAL OR NEGLIGIBLE BEARING, THEREFORE LITTLE OR NO FURTHER CONSEQUENCE SHOULD BE EXPECTED FROM THIS EVENT. THE CAUSE FOR SELF-UNSCREWING OF THE INSERT SCREW IS NOT KNOWN: ONE POSSIBILITY IS INSUFFICIENT TIGHTENING TORQUE, BUT OTHER UNKNOWN CONDITIONS MAY ALSO PLAY A ROLE.

    Description of Event or Problem · 1

    DURING ROUTINE FOLLOW-UP 8 MONTHS AFTER PRIMARY, THE STUDY ASSISTANT NOTICED ON THE PATIENTS X-RAY THAT THE SCREW IN THE INSERT APPEARED TO BE IN THE INCORRECT POSITION. THE X-RAY WAS SENT TO MEDACTA INTERNATIONAL FOR EXAMINATION BY A KNEE BIOENGINEER WHO CONFIRMED (ON (B)(6) 2017) THAT THE SCREW WAS NOT FIXED AND WHILST THE SCREW HAD NOT MIGRATED OUT COMPLETELY WAS DEFINITELY MIGRATING OUT. THE ADVICE GIVEN WAS TO INFORM THE SURGEON AND REMOVE THE SCREW AS SOON AS POSSIBLE BEFORE DAMAGE TO ARTICULATING SURFACES CAN OCCUR. THE PATIENT PRESENTED AT EMERGENCY DEPARTMENT ON (B)(6) WITH PAIN IN HER KNEE AND WAS SENT TO SURGERY WHEN, ON X-RAY, IT WAS NOTICED THE SCREW WAS SITTING IN THE LATERAL POCKET OF THE KNEE. THE SURGEON, USING SCOPE, REMOVED THE SCREW AND IDENTIFIED SMALL SCRATCHES ON, WHAT APPEARS TO BE, A NON ARTICULATING PART OF THE FEMORAL IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542444 GMK SPHERE TIBIAL INSERT FIXED TIBIAL INSERT SIZE 1 / 10 MM RIGHT JWH MEDACTA INTERNATIONAL SA 142847 07630030825941

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention