BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 51

    MDR report key: 2211689 · Received August 10, 2011

    Report

    Report Number
    1818910-2011-13959
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 11, 2011
    Report Date
    March 28, 2014
    Manufacturer
    DEPUY INTL, LTD
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT STATES: LITIGATION PAPERS ALLEGE THE PATIENT WILL NEED REVISION SURGERY TO ADDRESS HIP PAIN. DOI: (B)(6) 2010 - NO REVISION (RIGHT SIDE). UPDATE: (B)(6) 2011 - THE SALES REP REPORTED THE REVISION SURGERY. THE PATIENT WAS REVISED TO ADDRESS METAL SENSITIVITY - ELEVATED METAL ION LEVELS. DOI: (B)(6) 2010 - DOR: (B)(6) 2011. 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. REF. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION 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.

    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. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE, THE PT WILL NEED REVISION SURGERY TO ADDRESS HIP PAIN. UPDATE: (B)(6) 2011 - THE SALES REP REPORTED THE REVISION SURGERY. THE PT WAS REVISED TO ADDRESS METAL SENSITIVITY - ELEVATED METAL ION LEVELS.

    Description of Event or Problem · 1

    UPDATE REC'D (B)(4) 2014 - MEDICAL RECORDS RECEIVED. MEDICAL RECORDS INDICATE UPON REVISION AN INFLAMMATORY APPEARANCE AND STAINING OF THE SYNOVIUM SUGGESTIVE OF METAL DEBRIS AND ONLY PARTIALLY FIBROUS INGROWTH OF THE CUP WERE NOTED. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION. THE COMPLAINT WAS UPDATED ON: (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 51 87KWA KWA DEPUY INTL, LTD NA 3004801

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention