BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SP2 TIBIAL RADEL IMPACTOR

    MDR report key: 4241207 · Received November 10, 2014

    Report

    Report Number
    1818910-2014-31463
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED IMPACTOR CONFIRMS THE FRACTURE INITIATION ALONG THE SLOT THAT CONNECTS WITH THE UNIVERSAL HANDLE. THE ROOT CAUSE IS ATTRIBUTED TO MISUSE THROUGH MIS-ALIGNMENT. THE FLAT OF THE IMPACTOR EXHIBITS GOUGING/DAMAGE INDICATING THE IMPACTOR WAS NOT PROPERLY ALIGNED PRIOR TO IMPACTION. NO EVIDENCE WAS FOUND INDICATING PRODUCT ERROR WAS A CONTRIBUTING FACTOR. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. MONITOR THROUGH TREND ANALYSIS SEP-419. DEPUY CONSIDERS THE INVESTIGATION CLOSED. 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

    THE TIBIAL IMPACTOR BROKE IN HALF DURING INSERTION OF THE TIBIAL TRAY. ALL OF THE PIECES WERE RETRIEVED AND IT WAS FELT THAT NOTHING WAS LEFT IN THE PATIENT. NO DELAY OCCURED WITH THE SURGERY AND A SIMILAR PRODUCT WAS USED TO COMPLETE THE TIBIAL TRAY INSERTION. WE HAVE BEEN UNABLE TO COLLECT THE BROKEN TIBIAL IMPACTOR FROM THE HOSPITAL. IT IS BELIEVED THAT IT WAS DISCARDED WITH AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724016 SP2 TIBIAL RADEL IMPACTOR KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. SY1213

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention