BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE CONV SHIM SZ5 16MM

    MDR report key: 6053816 · Received October 25, 2016

    Report

    Report Number
    1818910-2016-30110
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    September 28, 2016
    Report Date
    September 28, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HWT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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. (B)(4). 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

    EXAMINATION OF THE RETURNED DEVICES CONFIRMS THE REPORTED EVENT OF TRIAL DAMAGE/BREAKAGE. THE OBSERVED CRACKING IS INITIATING AROUND THE METAL INSERT OF THE TRIALS A PRA 103121982 (PRELIMINARY RISK ASSESSMENT) MEETING WAS HELD TO DISCUSS A PRODUCT ESCALATION OUT OF AUSTRALIA CONCERNING THE ATTUNE SHIMS. THE TEAM HAS DETERMINED THAT THERE IS NO ADDITIONAL PATIENT RISK ASSOCIATED WITH THIS ISSUE. ALTHOUGH CRACKS ARE OCCURRING, THIS FAILURE MODE DOES NOT LEAD TO A PATIENT HARM OF INFECTION. THE RATE OF INFECTION FOR ATTUNE IS WITHIN THE STATE RATE IN THE RISK MANAGEMENT REPORT AND IS STATISTICALLY SIMILAR TO THE RATE OF INFECTION FOR THE TOTAL KNEE CLASS. ALTHOUGH A DEFINITIVE ROOT CAUSE IS NOT KNOWN, A COMBINATION USER TECHNIQUE, IMPROPER TECHNIQUE OR MISUSE, AND THE USE OF CONTRAINDICATED CHEMICALS (NON-COMPLIANT TO CLEANING GUIDELINES), MAY LEAD TO WEAKENING OF THE MATERIAL, AS SEEN IN THE RETURNED DEVICES. BASED ON THE PERFORMED INVESTIGATION AND PRA 103121982 DETERMINATION OF NO ADDITIONAL PATIENT RISK, CORRECTIVE ACTION IS NOT INDICATED. CONTINUE TO MONITOR VIA (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE 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 SHIM IS BROKEN IN PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705976 ATTUNE CONV SHIM SZ5 16MM KNEE INSTRUMENT/TRIAL HWT DEPUY ORTHOPAEDICS, INC. BFA0QC5

    Patients

    Seq Age Sex Outcome Treatment
    1