BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS 3 PEG ROT PATELLA CEM STD

    MDR report key: 2970275 · Received February 20, 2013

    Report

    Report Number
    1818910-2013-12621
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    September 15, 2008
    Report Date
    January 31, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    HTG
    PMA / PMN Number
    PP830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. 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 ABOUT THE ROOT CAUSE OF THE REPORTED EVENT BASED ON THE PROVIDED INFORMATION. THE INVESTIGATION DID NOT REVEAL ANY EVIDENCE SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND 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.

    Description of Event or Problem · 1

    PATIENT'S MEDICAL RECORDS RECEIVED. RECORDS INDICATE THE PATIENT WAS REVISED TO ADDRESS A FAILED KNEE IMPLANT. UPON REVISION POLYWEAR OF THE PATELLA WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73160 LCS 3 PEG ROT PATELLA CEM STD PATELLA HTG 1818910 DEPUY ORTHOPAEDICS, INC. U18C71018

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention