BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS PATELLA

    MDR report key: 2033702 · Received March 17, 2011

    Report

    Report Number
    1818910-2011-03864
    Event Type
    Injury
    Date Received
    March 17, 2011
    Report Date
    February 15, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES AND/OR PATIENT X-RAYS WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PROVIDED PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN 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

    THE PATIENT PRESENTED WITH ANTERIOR KNEE PAIN. PATIENT REQUIRED A PATELLA REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS PATELLA TOTAL KNEE PROSTHESIS JWH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention