BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SP2 IM ROD 400MM

    MDR report key: 3883430 · Received June 19, 2014

    Report

    Report Number
    1818910-2014-21512
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 30, 2014
    Manufacturer
    1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION AND JUSTIFICATION: EXAMINATION OF THE SUBMITTED INSTRUMENT CONFIRMED THE REPORTED BREAKAGE. PATIENT X-RAYS WERE NOT AVAILABLE. THE PRODUCT RETURNED IS OF A PRIOR DESIGN. A CONCLUSIVE ROOT CAUSE WAS NOT IDENTIFIED. ALTHOUGH THE DESIGN HAS BEEN ENHANCED SINCE THE COMPLAINT SAMPLE WAS MANUFACTURED, THE ROD BREAKAGE MAY ALSO BE RELATED TO A COMBINATION OF INSTRUMENT AGE, SERVICE LIFE, AND/OR USER TECHNIQUE. IN RESPONSE TO A TREND IDENTIFIED PREVIOUSLY FOR THIS PRODUCT CODE, ECO 38013 WAS RELEASED IN JULY OF 2001 CHANGING THE RAW MATERIAL USED AND THE GEOMETRY OF THE ROD. 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.

    Description of Event or Problem · 1

    IM ROD FRACTURED AT NIPPLES TIP. THE IM ROD WAS DISCOVERED TO BE INCOMPLETE DURING DECONTAMINATION. THE PATIENT WAS XRAYED AND THE BROKEN PIECE WAS IN THE PATIENCE TIBIAL CANAL THE HOSPITAL HAVEN'T LOGGED THIS AS A COMPLAINT. THEY PHONED ME TO REPLACE THE INSTRUMENT. I WAS IN THE HOSPITAL LAST NIGHT AND GAINED MORE INFORMATION SO I AM LOGGING THIS AS AN INCIDENT. THE PATIENT'S BONE WAS HARD AND I HAVE BEEN TOLD BY THE ASSISTANT THAT FORCE WAS USED TO INSERT THIS INTO THE CANAL. THEY WERE NOT AWARE THAT THIS WAS BROKEN UNTIL THE FOLLOWING DAY. I HAVE THE IM ROD WITH A DECONTAMINATION FORM. IF YOU NEED ANY MORE INFORMATION PLEASE LET ME KNOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361473 SP2 IM ROD 400MM KNEE INSTRUMENT/TRIAL LXH 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR