BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEM / SHAFT ASSY - 7.5MM

    MDR report key: 8354303 · Received February 20, 2019

    Report

    Report Number
    1651501-2019-00005
    Event Type
    Malfunction
    Date Received
    February 20, 2019
    Date of Event
    January 21, 2019
    Report Date
    February 6, 2019
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    KWI
    PMA / PMN Number
    K032806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE KATALYST HEAD AND STEM WERE RETURNED TO INTEGRA AND UNDERWENT FAILURE ANALYSIS. THE HEAD AND STEM WERE RETURNED SEPARATED, AND DIMENSIONAL AND VISUAL INSPECTION WAS PERFORMED. AS RECEIVED, THERE WERE NO ANOMALIES NOTICED ON THE KATALYST STEM. THE DEVICE WAS DIMENSIONALLY INSPECTED, AND ALL DIMENSIONS WERE WITHIN THE SPECIFIED TOLERANCES. AS RECEIVED, THERE WERE NO ANOMALIES NOTICED ON THE KATALYST HEAD, WITH THE EXCEPTION OF THE POLY INSERT. THIS PIECE CONTAINED COME SCRATCHES THAT APPEAR TO BE NORMAL WEAR AND TEAR FROM THE IMPLANT/EXPLANT PROCESS. ALL MEASUREMENTS OF THE HEAD/POLY ASSEMBLY MEASURED WITHIN SPECIFICATION WITH THE EXCEPTION OF THE INSERT LENGTH (5.40+0.00, MEASURED 5.86). CONSIDERING THE POLY MATERIAL IS EXPECTED TO GIVE TO ACCOMMODATE STEM INSERT, AND THE ASSEMBLY WAS CONSTRUCTED AND DECONSTRUCTED, THIS DOES NOT REPRESENT A FAILURE. BASED ON THE INFORMATION TO DATE, THE ROOT CAUSE FOR THE EVENT IS UNKNOWN. FAILURE ANALYSIS SHOWS THE DEVICE IS WITHIN SPECIFICATION GIVEN THE CONDITIONS OF USE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED - THE INCREASE OF SURGERY TIME DIDN¿T HARM THE PATIENT; HOWEVER, THE ANESTHESIA TIME AND MEDICATION WERE INCREASED. THE PATIENT WAS REPORTED TO BE DOING FINE FOLLOWING IMPLANTATION OF OTHER PROTHESIS. REVIEW OF THE DHR FOR 221675 STEM / SHAFT ASSY - 7.5MM LOT KV0121 SHOWED NO ANOMALIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.. BASED ON THE INFORMATION TO DATE, THE ROOT CAUSE FOR THE EVENT IS UNKNOWN. THE PRODUCT HAS NOT BEEN RETURNED TO DATE; THEREFORE, NO FAILURE ANALYSIS CAN BE PERFORMED.

    Additional Manufacturer Narrative · 1

    DHR SHOWED NO ANOMALIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.. BASED ON THE INFORMATION TO DATE, THE ROOT CAUSE FOR THE EVENT IS UNKNOWN. THE PRODUCT HAS NOT BEEN RETURNED TO DATE; THEREFORE, NO FAILURE ANALYSIS CAN BE PERFORMED.

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    A SALES REPRESENTATIVE REPORTED THAT ON (B)(6) 2019 A KATALYST BIPOLAR RADIAL HEAD SYSTEM (221675 - STEM / SHAFT ASSY - 7.5MM) WAS USED DURING A SURGERY. THE SURGEON IMPLANTED THE RADIAL HEAD PROTHESIS AND CLOSED THE WOUND. HE DID RANGE OF MOTION TESTS AND THE PROTHESIS HEAD KEPT SEPARATING FROM THE STEM. HE RE-OPENED THE INCISION AND WENT ON TO EXCHANGE THE PROTHESIS WITH NEW CONSTRUCT. THE SURGEON ADVISED THAT THE EASE OF DISASSEMBLY OF THE HEAD/STEM CONSTRUCT OF THE EXPLANTED PROTHESIS IS NOT NORMAL. NO PATIENT INJURY REPORTED AND THE EVENT LEAD TO 30 MINUTES SURGICAL DELAY. 1 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 1651501-2019-00006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149234 STEM / SHAFT ASSY - 7.5MM KATALYST BIPOLAR RADIAL HEAD SYSTEM KWI ASCENSION ORTHOPEDICS KV0121

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR