BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY PINNACLE CUP

    MDR report key: 2113371 · Received May 20, 2011

    Report

    Report Number
    1818910-2011-08937
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    May 3, 2010
    Report Date
    April 20, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K062426
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: IN (B)(6) OF 2009, PATIENT WAS IMPLANTED WITH A DEPUY PINNACLE HIP ON HIS RIGHT SIDE. SEVERAL MONTHS AFTER THE SURGERY, PATIENT BEGAN EXPERIENCING DISCOMFORT AND PAIN IN HIS HIPS AND GROIN AREA. IT BECAME INCREASINGLY PAINFUL FOR HIM TO WALK AND MOVE HIS LEGS. IN (B)(6) OF 2010, PATIENT HAD REVISION SURGERY TO REMOVE THE DEPUY PINNACLE HIP BECAUSE OF SWELLING AND PAIN. DURING REVISION, DOCTORS NOTED THAT PATIENT'S WHITE BLOOD COUNT WAS EXTREMELY HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY PINNACLE CUP TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL, LTD. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention