BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC SIGMARP STB IN TR S4 10.0

    MDR report key: 5508909 · Received March 17, 2016

    Report

    Report Number
    1818910-2016-15654
    Event Type
    Malfunction
    Date Received
    March 17, 2016
    Date of Event
    February 29, 2016
    Report Date
    February 29, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: EXAMINATION OF THE SUBMITTED PFC SIGMA RP STB IN TR S4 10.0 CONFIRMS BREAKAGE. THE INSERT TRIAL EXHIBITS SCRATCHES, GOUGES, AND SOME DISCOLORATION SUGGESTING HEAVY USAGE AND NUMEROUS DECONTAMINATION PROCEDURES. A SEARCH OF THE COMPLAINT DATABASE AGAINST PRODUCT CODE 963141 DID NOT IDENTIFY ANY TREND OF DEVICE BREAKAGE. THE ROOT CAUSE IS ATTRIBUTED TO PRODUCT WEAR OUT FROM NORMAL USE AND SERVICING. THE PRODUCT IS OLD (MFG 2005) AND HAS BEEN SUBJECTED TO HEAVY USAGE. BASED ON THE DETERMINATION OF PRODUCT WEAR OUT FROM NORMAL USE AND SERVING AS THE ROOT CAUSE, AND THE LOW FREQUENCY OF REPORTED EVENTS, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. MONITOR THROUGH (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 TRIAL BROKE DURING REDUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163545 PFC SIGMARP STB IN TR S4 10.0 KNEE INSTRUMENTS LXH DEPUY ORTHOPAEDICS, INC. 1818910 H0505

    Patients

    Seq Age Sex Outcome Treatment
    1