BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM R

    MDR report key: 8825504 · Received July 25, 2019

    Report

    Report Number
    3005180920-2019-00610
    Event Type
    Injury
    Date Received
    July 25, 2019
    Date of Event
    June 27, 2019
    Report Date
    July 25, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862625
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 JULY 2019: LOT 161957: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUN-2016. EXPIRATION DATE: 2021-06-02. 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. CLINICAL EVALUATION PERFORMED ON 12 JULY 2019: 2.5 YEARS AFTER PRIMARY CEMENTED TOTAL KNEE ARTHROPLASTY, THE INSERT FIXATION SCREW GOT LOOSE IN THE JOINT. SCREW AND LINER WERE REMOVED. DURING THE SURGICAL PROCEDURE, VISUAL INSPECTION OF THE ARTICULAR SURFACES CAN BE PERFORMED. IN CASE OF NO OR MINIMAL DAMAGE, 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. PRELIMINARY INVESTIGATION PERFORMED ON 23-JULY-2019: REVISION SURGERY AFTER 2 YEARS AND A HALF FROM PRIMARY DUE TO SELF-UNSCREWING AND LOOSENING OF THE INSERT SAFETY SCREW. PRELIMINARY INVESTIGATION BASED ON THE PICTURE OF THE EXPLANTED TIBIAL INSERT AND ITS SECURE FIXATION SCREW. THE THREADED PART OF THE SCREW LOOKS PARTIALLY DAMAGED. THIS PART HAS BEEN PLASTICALLY PRESSED ONCE, BACKED OUT FROM THE BASEPLATE, WAS INTERPOSED BETWEEN THE FEMORAL COMPONENT AND THE TIBIA INSERT AND UNDERWENT TO THE BODY LOAD. SOME DENTS CAN BE NOTED ON THE ARTICULAR SURFACE OF THE INSERT THAT WAS DAMAGED BY THE SCREW. FEMORAL AND TIBIAL TRAY COMPONENTS HAVE NOT BEEN EXPLANTED, SO WE CAN SUPPOSE THAT THEY HAVE BEEN FOUND IN GOOD CONDITION DURING REVISION SURGERY. IN CASE OF NO OR MINIMAL DAMAGE, NO FURTHER CONSEQUENCES SHOULD BE EXPECTED FROM THIS EVENT. THE MOST-LIKELY CAUSE FOR SELF-UNSCREWING OF THE SCREW IS INSUFFICIENT TIGHTENING TORQUE. THIS SCREWDRIVER WITH A TORQUE LIMITATION (REF. 02.07.10.4577; TORQUE LIMITER SCREWDRIVER 3.5 NM), CURRENTLY MANDATORY, WAS NOT USED DURING THE PRIMARY SURGERY. OTHER UNKNOWN FACTORS MIGHT ALSO PLAY A ROLE IN THE EVENT. NO FURTHER CONSIDERATIONS CAN BE DONE BASING ON THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    ABOUT 2 YEARS AND A HALF AFTER PRIMARY THE SURGEON REVISED THE PATIENT KNEE FOR LINER FIXATION SCREW UNSCREWING. THE SURGEON REMOVED THE SCREW AND REVISED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619130 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 161957 07630030862625

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention