BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI-LOCK TI 11.3 LAT OFFSET

    MDR report key: 4233875 · Received November 6, 2014

    Report

    Report Number
    1818910-2014-31396
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    March 19, 2014
    Report Date
    November 3, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. - 1818910
    Product Code
    KWA
    PMA / PMN Number
    PK073570
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED. UDI: UNAVAILABLE. SEE SECTION D FOR ANY PRODUCT INFORMATION RECEIVED. THIS COMPLAINT IS THE SUBJECT OF LITIGATION OR A LEGAL CLAIM AND CURRENTLY COMPLETE PRODUCT DETAIL IS NOT AVAILABLE AT THIS TIME. A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED. (B)(4).

    Description of Event or Problem · 1

    UPDATE REC¿D 11/03/2014 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT WAS IDENTIFIED FROM PATIENT STICKER SHEET FOR SECOND HEAD. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 12/02/2014.

    Description of Event or Problem · 1

    LEGAL CLAIM RECEIVED. UPDATE REC'D (B)(4) 2014- LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES PAIN, POPPING, GRINDING, DIFFICULTY WALKING, ELEVATED METAL ION LEVELS, ACETABULAR LOOSENING, ACETABULAR FRACTURE, EXTENSIVE OSTEOLYSIS, METALLIC STAINING FLUID, PSEUDOCAPSULE, AND CORROSION. THE DOI WAS PROVIDED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712693 TRI-LOCK TI 11.3 LAT OFFSET HIP FEMORAL STEM/SLEEVE KWA DEPUY ORTHOPAEDICS, INC. - 1818910 ZN3FWB000

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR