BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10MM R

    MDR report key: 8133917 · Received December 5, 2018

    Report

    Report Number
    3005180920-2018-00963
    Event Type
    Injury
    Date Received
    December 5, 2018
    Date of Event
    November 6, 2018
    Report Date
    December 5, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826344
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 04 DECEMBER 2018: LOT 162627: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JUL-2016. EXPIRATION DATE: 2021-07-03. 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. VISUAL INSPECTION PERFORMED BY R&D KNEE MANAGER: LOOSENING OF THE INSERT SAFETY SCREW WAS NOTED ABOUT 1 YEAR AND 10 MONTHS AFTER PRIMARY SURGERY. SCREW BACKED OUT AND WAS FOUND LOOSENED IN THE JOINT. IT HAS BEEN REMOVED BY ARTHROSCOPY. SIGNS AND SCRATCHES CAN BE NOTED ON THE HEAD AND ON THE THREADED PART OF THE SCREW. IT IS NOT POSSIBLE TO ESTABLISH IF THESE SIGNS HAVE BEEN CAUSED DURING SCREW REMOVAL OR CAUSED ONCE, BACKED OUT FROM THE INLAY, THE SCREW WAS INTERPOSED BETWEEN THE FEMORAL COMPONENT AND THE TIBIA INSERT AND UNDERWENT TO THE BODY LOAD. TIBIAL INSERT, BASEPLATE AND FEMORAL COMPONENTS HAVE NOT BEEN EXPLANTED, SO WE CAN SUPPOSE THAT THEY HAVE BEEN FOUND IN GOOD CONDITION. THE MOST-LIKELY CAUSE FOR SELF-UNSCREWING OF THE SCREW AFTER FEW MONTHS FROM IMPLANTATION, WAS INSUFFICIENT TIGHTENING TORQUE. NO FURTHER CONSIDERATIONS CAN BE DONE BASING ON THE AVAILABLE INFORMATION . CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: ONE YEAR AND 10 MONTHS AFTER PRIMARY TKR THE INSERT FIXATION SCREW GOT LOOSE IN THE JOINT. IT WAS IMMEDIATELY REMOVED WITH AN ARTHROSCOPIC PROCEDURE. NO CONSEQUENCE SHOULD BE EXPECTED FOR THE ABSENCE OF THE SCREW IN THE FUTURE LIFE OF THE IMPLANT. THE CAUSE FOR SELF UNSCREWING OF THE INSERT FIXATION 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

    ABOUT 1 YEAR AND 10 MONTHS AFTER PRIMARY THE SURGEON DETECTED THE INLAY FIXATION SCREW UNSCREWED IN THE PATIENT, COMPLETELY BACKED OUT AND EMBEDDED IN THE SOFT TISSUES LATERALLY. PATIENT HAD NO SYMPTOMS, SCREW REMOVED SUCCESSFULLY THROUGH ARTHROSCOPIC SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973981 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 162627 07630030826344

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention