BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COR/TARI ANT STEM INSERT SHAFT

    MDR report key: 2101589 · Received May 5, 2011

    Report

    Report Number
    1818910-2011-06453
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 5, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED INSTRUMENT CONFIRMED THE REPORTED EVENT. PREVIOUS INVESTIGATIONS, INCLUDING EVALUATIONS BY A DEPUY MATERIAL SCIENTIST HAS DETERMINED THAT USE ERROR IS THE MOST LIKELY ROOT CAUSE. MANUFACTURING OR MATERIAL ERROR WAS NOT IDENTIFIED. IT IS HOWEVER RECOGNIZED THAT IMPROVEMENTS ARE POSSIBLE TO ALLEVIATE THIS ISSUE EVEN IF NOT USED PROPERLY. (B)(4) WAS APPROVED AND COMPLETED ON (B)(4)2010, WHICH INCLUDES IMPROVEMENTS TO BOLSTER THE DURABILITY OF THIS INSTRUMENT. PER COMMUNICATION WITH DEPUY ENGINEERING AND THE MANUFACTURING SUPPLIER ALL PRODUCT DELIVERED NO LATER THAN (B)(4) 2010, IS OF THE NEW DESIGN. AS A RESULT OF PRODUCT COMPLAINTS, A PRELIMINARY RISK ASSESSMENT (PRA) WAS PERFORMED; LEADING TO A HEALTH HAZARD EVALUATION (HHE). IT WAS ORIGINALLY DETERMINED IN THE HHE THAT IT WAS NOT NECESSARY TO PLACE EXISTING INVENTORIES ON HOLD OR CONDUCT ANY FIELD ACTIONS. IT IS KNOWN THAT THE HHE WAS SINCE REVISITED AND EXISTING INVENTORY OF THE OLD DESIGN/REVISION FOR THE CURVED INSERTERS WAS IN FACT SCRAPPED AND IS NO LONGER DISTRIBUTED. IT IS ALSO KNOWN THAT FOR THIS PRODUCT CODE, INSTRUMENTS OF THE OLDER DESIGN ARE NO LONGER DISTRIBUTED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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.

    Description of Event or Problem · 1

    DURING USE OF THE CORAIL STEEL ONE OF THE PINS IS BROKEN OFF OF THE INSERTER. IT IS POSSIBLE THAT THE BROKEN PIN IS STILL IN THE PT. THE BROKEN PIN WAS NOT VISIBLE ON THE AP AND LAT X-RAY. A FRACTURE ON THE FRONT OF THE FEMUR IS THE RESULT OF THE BROKEN PIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COR/TARI ANT STEM INSERT SHAFT 87 LXH LXH DEPUY ORTHOPAEDICS, INC. NA PG 1109

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR