BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MTL INS NEUT 36ID X 50OD

    MDR report key: 2202306 · Received August 8, 2011

    Report

    Report Number
    1818910-2011-14044
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    July 9, 2011
    Report Date
    July 9, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    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

    COMPLAINT REVIEW IDENTIFIED THAT IN THE ABSENCE OF PRODUCTS AND PATIENT X-RAYS, INSUFFICIENT INFORMATION HAS BEEN PROVIDED TO VERIFY THE REPORTED INCIDENT. THE COMPLAINT SHALL BE CLOSED WITH AN INDETERMINED CONCLUSION; IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD FURTHER INFORMATION BE RECEIVED, THEN THE COMPLAINT SHALL BE INVESTIGATED FURTHER. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT 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

    PT PRESENTED WITH HIP PAIN, DURING A REVISION SURGERY THERE WAS SYNOVITIS AND TISSUE BLACKENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINN MTL INS NEUT 36ID X 50OD TOTAL HIP PROSTHESIS LPH DEPUY ORTHOPAEDICS, INC. NA 2407736

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention