BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC STEM TRIAL EXTRACT

    MDR report key: 2930015 · Received January 25, 2013

    Report

    Report Number
    1818910-2013-11535
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    January 19, 2013
    Report Date
    January 19, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED INSTRUMENT CONFIRMED THE STEM TRIAL EXTRACTOR TIP HAS FRACTURED AND REMAINS INSIDE THE STEM TRIAL. THE ROOT CAUSE OF THE FRACTURED STEM TRIAL EXTRACTOR TIP IS ATTRIBUTED TO SUSPECTED MISUSE DURING REMOVAL OF THE STEM TRIAL FROM THE BONE CANAL. THE INVESTIGATION DID NOT FIND ANY EVIDENCE OF STEM TRIAL FAILURE OR PRODUCT CONTRIBUTION TO THE FRACTURED STEM TRIAL EXTRACTOR THREADED TIP. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT FAILURE OR PRODUCT CONTRIBUTION AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED INSTRUMENT CONFIRMED THE THREADED TIP HAS FRACTURED AND THE HANDLE COMPONENT HAS BECOME DISASSEMBLED. THE ROOT CAUSE OF THE DISASSEMBLED HANDLE COMPONENT IS MANUFACTURING PROCESS RELATED. THE ROOT CAUSE OF THE FRACTURED TIP IS ATTRIBUTED TO SUSPECTED MISUSE DURING REMOVAL OF THE STEM TRIAL FROM THE BONE CANAL. THERE IS EVIDENCE SUGGESTING THE INSTRUMENT WAS LEVERED SIDE TO SIDE IN ATTEMPTS TO REMOVE THE STEM TRIAL. NO CORRECTIVE ACTION REQUIRED FOR THE FRACTURED STEM TRIAL EXTRACTOR TIP, AS THE ROOT CAUSE WAS ATTRIBUTED TO MISUSE AND NO EVIDENCE OF PRODUCT ERROR AS A CONTRIBUTING FACTOR. NO CORRECTIVE ACTION REQUIRED FOR THE CONFIRMED DISASSEMBLED HANDLE COMPONENT, AS A PREVIOUS PRODUCT ENHANCEMENT HAS BEEN IMPLEMENTED. THE CHANGE WENT INTO EFFECT AT THE SUPPLIER IN (B)(4) 2009. THE RETURNED DEVICE WAS MANUFACTURED IN FEBRUARY 2009, PRIOR TO THE IMPROVEMENT. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    TRIAL UNIVERSAL STEM BECAME STUCK IN TIBIAL CANAL. THE STEM TRIAL EXTRACTOR BROKE WHEN THE SURGEON TRIED TO USE IT. THREADED END BROKE OFF IN STUCK TRIAL STEM AND HANDLE DISASSOCIATED FROM SHAFT ALSO. THIS CAUSED A SURGICAL DELAY OF APPROX 60 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35841 PFC STEM TRIAL EXTRACT KNEE INSTRUMENT LXH DEPUY ORTHOPAEDICS, INC. G0209

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention