BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN UNKNOWN

    MDR report key: 2963336 · Received December 19, 2012

    Report

    Report Number
    1651501-2012-00053
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 1, 2011
    Report Date
    December 19, 2012
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    KWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CROSS REFERENCED TO VOLUNTARY REPORT NUMBER: (B)(4). IT IS UNKNOWN IF THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS EXPECTED TO BE RETURNED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A TOTAL SHOULDER REPLACEMENT SURGERY USING THE TITAN MODULAR SHOULDER SYSTEM. IN POST-SURGERY CONSULT, THE PHYSICIAN STATED "SURGERY WENT WELL, BONE IS GOOD." BEFORE LEAVING THE HOSPITAL, THE PATIENT FELT AND STATED TO THE MEDICAL STAFF THAT THE IMPLANT FELT LOOSE. THE PATIENT STATED THE SAME TO THE DOCTOR AT FIRST AND SECOND POST-SURGERY VISITS AND COMPLAINED OF INCREASING PAIN. IN 2011, AT THE 3RD POST-SURGERY VISIT, THE PHYSICIAN AGREED TO CT THE SHOULDER WHEN IT WAS DISCOVERED THAT THE IMPLANT SPUN AROUND, THE HEAD HAD HUNG UP ON THE GLENOID, AND THE IMPLANT WAS RISING OUT OF THE HUMERUS. A REVISION SURGERY WAS THEN PERFORMED IN 2011 DURING WHICH THE PHYSICIAN USED A LARGER IMPLANT AND CEMENTED IT IN PLACE. IN POST-REVISION SURGERY CONSULT, THE PHYSICIAN STATED "IT COULDN'T BE HELPED THE BONE IS SOFT." THE PATIENT SUFFERED NERVE DAMAGE, CONTINUOUS PAIN, AND MUCH MORE LIMITED RANGE OF MOTION THAN BEFORE THE INITIAL SURGERY. THE PATIENT HAD MULTIPLE PHYSICAL THERAPY DATES UNTIL INSURANCE CEASED THE COVERAGE. THE PATIENT CONTINUES TO SEE A DIFFERENT PHYSICIAN FOR THE NERVE PAIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TITAN UNKNOWN TITAN TOTAL SHOULDER KWS ASCENSION ORTHOPEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention