BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ROM*FRAME,TRIANGLE MILLER

    MDR report key: 3685547 · Received March 18, 2014

    Report

    Report Number
    1818910-2014-14683
    Event Type
    Malfunction
    Date Received
    March 18, 2014
    Date of Event
    February 26, 2014
    Report Date
    February 26, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. FOLLOW UP COMMUNICATION FOR PRODUCT RETURN WAS UNSUCCESSFUL. A COMPLAINT DATABASE SEARCH FOUND SIMILAR INCIDENTS WHICH WERE ATTRIBUTED TO PRODUCT WEAR OUT AND OR MISUSE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS 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

    ADDITIONAL NARRATIVE: EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE REPORTED EVENT. THE TIP OF THE DEVICE IS FRACTURED. A COMPLAINT DATABASE SEARCH DID NOT IDENTIFY A TREND OF THE REPORTED EVENT. BASED ON THE AGE AND OVERALL CONDITION OF THE RETURNED DEVICE, THE ROOT CAUSE IS ATTRIBUTED TO PRODUCT WEAR OUT. BASED ON THE ROOT CAUSE OF PRODUCT WEAR OUT, CORRECTIVE ACTION IS NOT NEEDED. SUBSEQUENT REPORTS WILL BE MONITORED THROUGH (B)(4). DEPUY CONSIDERS THIS 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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

    TRIANGLE MILLER FRAME FROM THE CONSIGNED SROM HIP SET AT IRO BROKE DURING A CASE ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159396 S-ROM*FRAME,TRIANGLE MILLER HIP INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. B0193

    Patients

    Seq Age Sex Outcome Treatment
    1 Other