BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN SECTOR W/GRIPTION 58MM

    MDR report key: 3931271 · Received July 14, 2014

    Report

    Report Number
    1818910-2014-23246
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 20, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK071784
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    CUP, LINER, SCREWS REMOVED AND REPLACED DUE TO LOOSENING AND DISLOCATION. THE FEMORAL HEAD WAS CHANGED AS WELL. THE ACETABULAR CUP WAS FOUND TO BE LOOSE.EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE 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

    CUP, LINER, SCREWS REMOVED AND REPLACED DUE TO LOOSENING AND DISLOCATION. THE FEMORAL HEAD WAS CHANGED AS WELL. THE ACETABULAR CUP WAS FOUND TO BE LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410902 PINN SECTOR W/GRIPTION 58MM HIP ACETABULAR CUP LPH DEPUY ORTHOPAEDICS, INC. 483105

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention