BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI-LOCK BPS SZ 4 STD OFFSET

    MDR report key: 3771658 · Received April 24, 2014

    Report

    Report Number
    1818910-2014-17468
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    November 28, 2011
    Report Date
    May 27, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. - 1818910
    Product Code
    KWA
    PMA / PMN Number
    PK073570
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

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

    ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UPDATE REC¿D (B)(4) 2014 - MEDICAL RECORDS RECEIVED. PATIENT WAS REVISED TO ADDRESS YELLOW-BROWN FLUID COLLECTION, SYNOVIAL REACTIVE TISSUE, AND CORROSION. THE ADAPTER SLEEVE AND FEMORAL STEM ARE NOW BEING ADDED TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON: (B)(4) 2014. EXAMINATION OF THE REPORTED DEVICE WAS NOT POSSIBLE AS IT WAS NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATION SINCE ITS 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

    NEW ETQ CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT- LITIGATION PAPERS ALLEGE PAIN AND PROBLEMS. ADDITIONALLY IT IS ALLEGED THE PATIENT WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT. UPDATE: (B)(6) 2013- SALES REP REPORTED REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS PAIN. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: (B)(6) 2014. UPDATE: (B)(6) 2014 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOR INFORMATION. THE DOR FROM THE PPD MATCHES THE DATE FROM THE DER, WHICH WAS ORIGINALLY ENTERED INCORRECTLY. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. COMPLAINT WAS UPDATED ON (B)(6) 2014. UPDATE REC¿D (B)(6) 2014 - MEDICAL RECORDS RECEIVED. PATIENT WAS REVISED TO ADDRESS YELLOW-BROWN FLUID COLLECTION, SYNOVIAL REACTIVE TISSUE, AND CORROSION. THE ADAPTER SLEEVE AND FEMORAL STEM ARE NOW BEING ADDED TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON: (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250081 TRI-LOCK BPS SZ 4 STD OFFSET HIP FEMORAL STEM/SLEEVE KWA DEPUY ORTHOPAEDICS, INC. - 1818910 CY6EK1000

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR