BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC STEM TRIAL EXTRACT

    MDR report key: 3964282 · Received July 29, 2014

    Report

    Report Number
    1818910-2014-24340
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 25, 2014
    Manufacturer
    1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    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. 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

    THE INSTRUMENT ASSOCIATED WITH THE REPORTED EVENT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND PREVIOUS REPORTS OF THE 865226 PFC STEM TRIAL EXTRACT THREADED TIPS BREAKING DURING EXTRACTION OF PFC FLUT TIB ROD TRIALS. PREVIOUS INVESTIGATIONS IDENTIFIED EVIDENCE OF THE 865226 PFC STEM TRIAL EXTRACT BEING LEVERED SIDE TO SIDE WHICH RESULTED IN THE BREAKAGE. THE CURRENT INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT THE INSTRUMENT TO EXAMINE. BASED ON THE INABILITY TO CONFIRM THE REPORTED EVENT OR DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE, NO CORRECTIVE ACTION IS INDICATED. 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.

    Description of Event or Problem · 1

    STEM GOT STUCK AND COULD NOT GET OUT. END OF SCREWDRIVER TIP BROKE OFF IN STEM TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442359 PFC STEM TRIAL EXTRACT KNEE INSTRUMENT/TRIAL LXH 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR