BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFCSIGMA POST FEMAUG TRL4MM S3

    MDR report key: 6394580 · Received March 10, 2017

    Report

    Report Number
    1818910-2017-14345
    Event Type
    Malfunction
    Date Received
    March 10, 2017
    Date of Event
    February 17, 2017
    Report Date
    March 13, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT REMAINS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED. (B)(4). FOLLOWUP WITH THE COMPLAINANT HAS BEEN CONDUCTED FOR THE LOT NUMBER, AND THE INFORMATION IS NOT AVAILABLE. 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 COMPLAINT STATES KNEE REPLACEMENT. A STEM TRIAL CANNOT BE PLACED ON THE TIBIAL TRIAL AS THE END IS DAMAGED. THE POSTERIOR AUGMENT STUB HAS COME OFF. A COMPLAINT DATABASE SEARCH DID NOT IDENTIFY ANY ANOMALIES. NO DEVICES WERE RETURNED BUT PHOTOS WERE WHICH WERE REVIEWED BY DEPUY ENGINEERING (B)(4). THE DEVICES REPORTED IN THIS CASE HAVE BEEN ASSESSED BY DEPUY ENGINEERING IN (B)(4) WITH THE FOLLOWING RESOLUTION: ATTACHMENT ONE SHOWS THE 965383 TIBIAL TRAY IMPACTOR. AS CAN BE SEEN THE IMPACTOR IS BADLY SCRATCHED AND DAMAGED. THE LOT I/D OF J0805 (AUG 2005) MAKES THIS INSTRUMENT APPROX. 12YRS OLD. (COVERED IN (B)(4)). ATTACHMENT TWO SHOWS THE 229435130 REV TRAY TRL W/STEM SZ3. AS CAN BE SEEN THE STEM TRIAL ENTRY POINT HAS BEEN BENT. THE LOT I/D OF H0910 (SEPT 2010) MAKES THIS INSTRUMENT APPROX. 6+ YRS. OLD. ATTACHMENT THREE SHOWS THE 961866 SIGMA POST TRL 4 SZ3. AS CAN BE SEEN THE TRIAL LOCATION POST HAS BROKEN OFF. THE LOT I/D OF GM0999 (SEPT 1999) MAKES THIS INSTRUMENT APPROX. 17+ YRS. OLD. THE ROOT CAUSE OF THE REPORTED EVENT HAS BEEN ATTRIBUTE TO WEAR AND TEAR. THE DEVICES WILL BE DISPOSED OF. (SB) THE ROOT CAUSE OF THE REPORTED EVENT HAS BEEN ATTRIBUTE TO WEAR AND TEAR. THE COMPLAINT SHALL BE CLOSED WITH A JUSTIFIED CONCLUSION; ENTERED INTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    A STEM TRIAL CANNOT BE PLACED ON THE TIBIAL TRIAL AS THE END IS DAMAGED. THE POSTERIOR AUGMENT STUB HAS COME OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178848 PFCSIGMA POST FEMAUG TRL4MM S3 KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. GM0999

    Patients

    Seq Age Sex Outcome Treatment
    1