BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT FIXED SPHERE FLEX #4/11 MM L

    MDR report key: 7483274 · Received May 3, 2018

    Report

    Report Number
    3005180920-2018-00293
    Event Type
    Injury
    Date Received
    May 3, 2018
    Date of Event
    April 24, 2018
    Report Date
    May 3, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862601
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 02 MAY 2018; LOT 142498: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 SEPTEMBER 2014. EXPIRATION DATE: 2022-02-13; 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 BY MEDICAL AFFAIRS MANAGER ON 03 MAY 2018: 1,5 YEARS AFTER PRIMARY TKA THE INSERT FIXATION SCREW GOT LOOSE IN THE JOINT. IMMEDIATE REMOVAL IS STRONGLY RECOMMENDED. NO CONSEQUENCE SHOULD BE EXPECTED FOR THE ABSENCE OF THE SCREW IN THE FUTURE LIFE OF THE IMPLANT. DURING REOPERATION, ARTICULAR SURFACES MUST BE VISUALLY CHECKED TO AVOID DAMAGE TO THE FEMORAL COMPONENT. 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 CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THE SCREW BACKED OUT OF THE SPHERE POLY. THE TORQUE DRIVER WAS NOT USED IN THE PRIMARY SURGERY. THE SURGEON REVISE THE SCREW ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328183 TIBIAL INSERT FIXED SPHERE FLEX #4/11 MM L TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 142498 07630030862601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention