BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY CERAMIC HEAD 28+0 9/10 TAPER

    MDR report key: 2121390 · Received June 1, 2011

    Report

    Report Number
    1818910-2011-08220
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LZO
    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 DEVICE AND/OR PATIENT X-RAYS WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. SEVERAL FOLLOW UP ATTEMPTS WERE ATTEMPTED TO OBTAIN ADDITIONAL PATIENT DEMOGRAPHICS, PRODUCT INFORMATION, AND X-RAYS BUT WERE UNSUCCESSFUL. REVIEW OF DEVICE HISTORY RECORDS OF THE PROVIDED PRODUCT/LOT CODE COMBINATIONS 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. 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

    REASON OF REVISION: PT WAS IN PAIN ON LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY CERAMIC HEAD 28+0 9/10 TAPER TOTAL HIP REPLACEMENT LZO DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention