BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9/10 COCR HEAD 28MM +0

    MDR report key: 2060636 · Received April 6, 2011

    Report

    Report Number
    1818910-2011-04820
    Event Type
    Injury
    Date Received
    April 6, 2011
    Report Date
    March 7, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    K871867
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 RETURNED LINER AND FEMORAL HEAD WAS NOT ABLE TO DETERMINE ROOT CAUSE OF THE REPORTED DISLOCATION. THE REPORTED STEM WAS NOT EXPLANTED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. A REVIEW OF DEVICE HISTORY RECORDS AND MATERIAL CERTIFICATIONS DID NOT IDENTIFY ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. A REVIEW OF THE COMPLAINTS DATABASES AND OR REVIEW OF THE REPLICA STEM DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE REQUIRED LOT CODE WAS NOT PROVIDED. REVIEW OF PROVIDED PATIENT X-RAYS BY DEPUY BIOENGINEERING COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE REPORT. 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.

    Description of Event or Problem · 1

    IN (B)(6) 2010, MEDIAL DISLOCATION OF FEMUR OCCURRED. WHEN MANUAL REDUCTION WAS PERFORMED TO TREAT THE DISLOCATION, DISLOCATION OF THE HEAD OUT OF NECK OCCURRED. ON (B)(6) 2010, RE-SURGERY WAS DONE AND THE HEAD AND LINER WERE REPLACED. DURING SURGERY, IT WAS NOTED THAT THE STEM NECK WAS DARKENED. THE STEM WAS NOT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9/10 COCR HEAD 28MM +0 87JDI JDI DEPUY ORTHOPAEDICS, INC. NA 1986193

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention