BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COR/TRI ANT STEM INSERT SHAFT

    MDR report key: 3013317 · Received March 20, 2013

    Report

    Report Number
    1818910-2013-14153
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    July 16, 2012
    Report Date
    February 25, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    UPDATED: THE INSTRUMENT HAS NOT BEEN RETURNED FOR EXAMINATION. IT IS HOWEVER KNOWN THAT TIP FRACTURE CAN OCCUR WHEN USING THIS INSTRUMENT IMPROPERLY. PREVIOUS INVESTIGATIONS, INCLUDING EVALUATIONS BY A DEPUY MATERIAL SCIENTIST HAS DETERMINED THAT USE ERROR, IN IMPACTING THE SHAFT WHEN NOT PROPERLY ALIGNED WITHIN THE MATING STEM, IS THE ROOT CAUSE. MANUFACTURING OR MATERIAL ERROR HAS NOT PREVIOUSLY BEEN IDENTIFIED. IT WAS HOWEVER RECOGNIZED THAT IMPROVEMENTS WERE POSSIBLE TO ALLEVIATE THIS ISSUE EVEN IF NOT USED PROPERLY. (B)(4) WAS APPROVED AND COMPLETED ON JANUARY 15, 2010, WHICH INCLUDES IMPROVEMENTS TO BOLSTER THE DURABILITY OF THIS INSTRUMENT. THE COMPLAINANT HAS NOT PROVIDED A MANUFACTURING LOT CODE. THE INVESTIGATION IS NOT ABLE TO DETERMINE IF MANUFACTURED PRIOR OR POST THE DESIGN IMPROVEMENTS. CORRECTIVE ACTION NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EXAMINATION. IT IS HOWEVER KNOWN THAT TIP FRACTURE CAN OCCUR WHEN USING THIS INSTRUMENT IMPROPERLY. PREVIOUS INVESTIGATIONS, INCLUDING EVALUATIONS BY A DEPUY MATERIAL SCIENTIST HAS DETERMINED THAT USE ERROR, IN IMPACTING THE SHAFT WHEN NOT PROPERLY ALIGNED WITHIN THE MATING STEM, IS THE ROOT CAUSE. MANUFACTURING OR MATERIAL ERROR HAS NOT PREVIOUSLY BEEN IDENTIFIED. IT WAS HOWEVER RECOGNIZED THAT IMPROVEMENTS WERE POSSIBLE TO ALLEVIATE THIS ISSUE EVEN IF NOT USED PROPERLY. (B)(4) WAS APPROVED AND COMPLETED ON JANUARY 15, 2010, WHICH INCLUDES IMPROVEMENTS TO BOLSTER THE DURABILITY OF THIS INSTRUMENT. THE COMPLAINANT HAS NOT PROVIDED A MANUFACTURING LOT CODE. THE INVESTIGATION IS NOT ABLE TO DETERMINE IF MANUFACTURED PRIOR OR POST THE DESIGN IMPROVEMENTS. CORRECTIVE ACTION NOT INDICATED. 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.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EXAMINATION. IT IS HOWEVER KNOWN THAT TIP FRACTURE CAN OCCUR WHEN USING THIS INSTRUMENT IMPROPERLY. PREVIOUS INVESTIGATIONS, INCLUDING EVALUATIONS BY A DEPUY MATERIAL SCIENTIST HAS DETERMINED THAT USE ERROR, IN IMPACTING THE SHAFT WHEN NOT PROPERLY ALIGNED WITHIN THE MATING STEM, IS THE ROOT CAUSE. MANUFACTURING OR MATERIAL ERROR HAS NOT PREVIOUSLY BEEN IDENTIFIED. IT WAS HOWEVER RECOGNIZED THAT IMPROVEMENTS WERE POSSIBLE TO ALLEVIATE THIS ISSUE EVEN IF NOT USED PROPERLY. (B)(4) WAS APPROVED AND COMPLETED ON JANUARY 15, 2010, WHICH INCLUDES IMPROVEMENTS TO BOLSTER THE DURABILITY OF THIS INSTRUMENT. THE COMPLAINANT HAS NOT PROVIDED A MANUFACTURING LOT CODE. THE INVESTIGATION IS NOT ABLE TO DETERMINE IF MANUFACTURED PRIOR OR POST THE DESIGN IMPROVEMENTS. CORRECTIVE ACTION NOT INDICATED. 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.

    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

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EXAMINATION. IT IS HOWEVER KNOWN THAT TIP FRACTURE CAN OCCUR WHEN USING THIS INSTRUMENT IMPROPERLY. PREVIOUS INVESTIGATIONS, INCLUDING EVALUATIONS BY A DEPUY MATERIAL SCIENTIST HAS DETERMINED THAT USE ERROR, IN IMPACTING THE SHAFT WHEN NOT PROPERLY ALIGNED WITHIN THE MATING STEM, IS THE ROOT CAUSE. MANUFACTURING OR MATERIAL ERROR HAS NOT PREVIOUSLY BEEN IDENTIFIED. IT WAS HOWEVER RECOGNIZED THAT IMPROVEMENTS WERE POSSIBLE TO ALLEVIATE THIS ISSUE EVEN IF NOT USED PROPERLY. (B)(4) WAS APPROVED AND COMPLETED ON JANUARY 15, 2010, WHICH INCLUDES IMPROVEMENTS TO BOLSTER THE DURABILITY OF THIS INSTRUMENT. THE COMPLAINANT HAS NOT PROVIDED A MANUFACTURING LOT CODE. THE INVESTIGATION IS NOT ABLE TO DETERMINE IF MANUFACTURED PRIOR OR POST THE DESIGN IMPROVEMENTS. CORRECTIVE ACTION NOT INDICATED.

    Description of Event or Problem · 1

    PATIENT HAD HIP DONE ON (B)(6) 2012. THE TIP OF THE CORAIL INSERTER BROKE OFF AND WAS LEFT IN THE PATIENT. THIS WAS UNKNOWN UNTIL PATIENT CAME INFOR HER OTHER HIP ON (B)(6) 2013, AND IT SHOWED UP ON AN XRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115744 COR/TRI ANT STEM INSERT SHAFT HIP INSTRUMENT LXH DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention