BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 51

    MDR report key: 3132235 · Received May 29, 2013

    Report

    Report Number
    1818910-2013-05995
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    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

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

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD PAIN, SWELLING, INFLAMMATION, DAMAGE TO BONE AND TISSUE, PERMANENT DISABILITIES, AND IS AT RISK FOR HIGH LEVELS OF CHROMIUM AND COBALT IN BLOOD FROM METAL DEBRIS AFTER ASR HIP IMPLANT.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOB AND PRODUCT/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4. REASON FOR ORIGINAL COMPLAINT - LITIGATION ALLEGES PATIENT HAD PAIN, SWELLING, INFLAMMATION, DAMAGE TO BONE AND TISSUE, PERMANENT DISABILITIES, AND IS AT RISK FOR HIGH LEVELS OF CHROMIUM AND COBALT IN BLOOD FROM METAL DEBRIS AFTER ASR HIP IMPLANT. DOI: (B)(6) 2007 (RIGHT HIP). DOR: NONE REPORTED. PATIENT IS RESIDENT OF (B)(6). UPDATE - (B)(6) 2013 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOB AND PRODUCT/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE REC'D (B)(6) 2014 - REVISION DATE - REASON FOR REVISION PATIENT WANTED ASR REMOVED NO OTHER REASONS GIVEN - PATIENT DEMOGRAPHICS - SURGEON NAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237310 ASR UNI FEMORAL IMPL SIZE 51 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL 2401073

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other| R