BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/10MM

    MDR report key: 6511298 · Received April 21, 2017

    Report

    Report Number
    3005180920-2017-00193
    Event Type
    Injury
    Date Received
    April 21, 2017
    Date of Event
    March 23, 2017
    Report Date
    April 21, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 07 APRIL 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: KNEE REVISION SURGERY IS REQUIRED 3 YEARS AFTER PRIMARY IMPLANTATION. RADIOGRAPHIC IMAGES SHOW THE PRESENCE OF A LOOSENED INSERT SCREW FIXATION. THIS EVENT MAY BE DUE TO INSUFFICIENT TIGHTENING TORQUE BUT THE REAL CAUSE CAN'T BE DETERMINED. IMMEDIATE REMOVAL IS STRONGLY RECOMMENDED. ADDITIONAL INFORMATION RECEIVED ON 19 APRIL 2017 AND INCLUDES: TO 19 APRIL 2017, THE REVISION WAS NOT DONE YET. BATCH REVIEW PERFORMED ON 19 APRIL 2017. LOT 121919: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 AUGUST 2012. EXPIRATION DATE: 2017-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ON 20 APRIL 2017 THE PATIENT MATCH DEPARTMENT PERFORMED A PLANNING REVIEW AND COMMENTED AS FOLLOWS: OUR ANALYSIS OF THE PLANNING PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. NO ERRORS HAVE BEEN FOUND IN ANY STEP. NOT YET EXPLANTED.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON NOTICED THE SCREW HAD BACKED OUT. THE CAUSE OF THE SCREW BACKING OUT IS UNKNOWN. THERE WAS NO TRAUMA TO THE KNEE. THE SURGEON PLANS TO REVISE THE KNEE. NO REVISION IS SCHEDULED AT THIS TIME. X-RAYS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292924 GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/10MM TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 121919

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention