BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY SZ 3 12.5MM PS FIXED TIBIAL INSERT

    MDR report key: 2093658 · Received May 12, 2011

    Report

    Report Number
    1818910-2011-08384
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. THE PRODUCT CODE AND LOT CODE REQUIRED IN SEARCHING THE COMPLAINT DATABASE WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE LACK OF THE PRODUCT TO EXAMINE AND INSUFFICIENT PRODUCT INFO. IT WAS NOTED THE PRODUCT WAS IMPLANTED FOR APPROX FIFTEEN YEARS PRIOR TO REVISION. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADD'L INFO BE REC'D, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS FEMORAL LOOSENING AT THE CEMENT/IMPLANT INTERFACE. THE MFR OF THE CEMENT USED IN THE PRIMARY SURGERY IS UNKNOWN. OSTEOLYSIS WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY SZ 3 12.5MM PS FIXED TIBIAL INSERT TOTAL KNEE PROSTHESIS JWH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention