BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/12MM

    MDR report key: 6860923 · Received September 13, 2017

    Report

    Report Number
    3005180920-2017-00515
    Event Type
    Injury
    Date Received
    September 13, 2017
    Date of Event
    August 15, 2017
    Report Date
    September 13, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817168
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 08 SEPTEMBER 2017 THE MEDICAL AFFAIRS PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: FIVE YEARS AFTER PRIMARY TOTAL KNEE ARTHROPLASTY, THE INSERT FIXATION SCREW GOT LOOSE IN THE JOINT. IT WAS IMMEDIATELY REMOVED, THE POLYETHYLENE INSERT WAS EXCHANGED AND FIXED WITH A NEW SCREW. DURING THE REVISION SURGERY IT WAS POSSIBLE TO ASSESS THE STATUS OF THE ARTICULAR SURFACES AND NO DAMAGE WAS REPORTED. NO 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. BATCH REVIEW PERFORMED ON 11 SEPTEMBER 2017. LOT 112544: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 DECEMBER 2011. EXPIRATION DATE: 2016-09-30. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THAT THE SCREW BACKED OUT OF THE TIBIAL INSERT. THE SURGEON WASHED OUT THE KNEE, SWAPPED THE POLY AND EXPLANTED THE SCREW. THE SURGEON USED THE SCREW WITH THE NEW POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642085 GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/12MM TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 112544 07630030817168

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention