BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS 3PEG MOD ROT PAT CEM STD+

    MDR report key: 2915803 · Received January 15, 2013

    Report

    Report Number
    1818910-2013-10965
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    NJL
    PMA / PMN Number
    PP830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. PER THE INITIAL REPORTING, PATIENT X-RAYS ARE NOT AVAILABLE FOR EXAMINATION. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE ROOT CAUSE OF THE REPORTED EVENT; HOWEVER, THE INITIAL REPORTING STATED PATIENT TRAUMA (NUMEROUS FALLS) WAS A POSSIBLE CONTRIBUTING FACTOR. IT IS STATED IN THE INITIAL PRODUCT INVESTIGATION REQUEST, IT WAS NOT SUSPECTED THAT THE DEVICE FAILED TO MEET SPECIFICATIONS OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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.

    Description of Event or Problem · 1

    DURING A REVISION TO ADDRESS FRACTURE OF THE PATIENT'S PATELLA BONE CAUSED BY NUMEROUS FALLS, POLY WEAR OF THE PATELLA WAS ALSO FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22806 LCS 3PEG MOD ROT PAT CEM STD+ PATELLA PROSTHESIS NJL DEPUY ORTHOPAEDICS, INC. Y5DJE1

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention