BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT CEM TIBIAL TRAY SZ3

    MDR report key: 2153131 · Received June 22, 2011

    Report

    Report Number
    1818910-2011-09670
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 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
    AU
    Reporter Occupation
    OTHER

    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

    EXAMINATION OF THE REPORTED DEVICE AND PATIENT X-RAYS IS UNABLE TO CONFIRM THE REPORTED EVENT. DIMENSIONAL AND VISUAL INSPECTION AS WELL AS RA SURFACE FINISH WAS CONDUCTED ON THE RETURNED SAMPLE FINDING ALL SPECIFICATIONS WERE MET. REVIEW OF DEVICE HISTORY RECORDS AND RAW MATERIAL CERTIFICATIONS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER SIMILAR 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.

    Description of Event or Problem · 1

    CEMENT (NON DEPUY PRODUCT) DIDN'T STICK TO THE TIBIA PLATEAU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MBT CEM TIBIAL TRAY SZ3 TOTAL KNEE REPLACEMENT JWH DEPUY ORTHOPAEDICS, INC. NA 3279643

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention