BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT FIXED SPHERE FLEX #2/10 MM L

    MDR report key: 7486995 · Received May 4, 2018

    Report

    Report Number
    3005180920-2018-00300
    Event Type
    Injury
    Date Received
    May 4, 2018
    Date of Event
    March 30, 2018
    Report Date
    May 4, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826139
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TORQUE DRIVER WAS NOT USED FOR THE PRIMARY SURGERY. BATCH REVIEW PERFORMED ON 03 MAY 2018. LOT 160092:30 ITEMS MANUFACTURED AND RELEASED ON 20 APRIL 2016. EXPIRATION DATE: 2021-04-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 20 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER ON 04 MAY 2018. ONE YEAR AND 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. 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

    THE PATIENT FELT PAIN 1 YEAR AND 6 MONTHS AFTER PRIMARY: THE FIXATION SCREW WAS FOUND UNSCREWED. THE SCREW WAS REMOVED ARTHROSCOPICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329445 TIBIAL INSERT FIXED SPHERE FLEX #2/10 MM L TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 160092 07630030826139

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention