BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 4130640 · Received September 30, 2014

    Report

    Report Number
    1818910-2014-29147
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    September 9, 2014
    Report Date
    January 13, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD.-8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    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. REF. (B)(4). DEPUY CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.    UDI: UNAVAILABLE. DEPUY SYNTHES HAS BEEN INFORMED THAT THE CATALOG NUMBER AND LOT NUMBER IS NOT AVAILABLE.

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

    Description of Event or Problem · 1

    UPDATE REC'D 01/13/2015- LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES PAIN, STIFFNESS, DIFFICULTY WALKING, AND ELEVATED METAL ION LEVELS. THE DOI WAS PROVIDED. THE INVOICE WAS LOCATED FOR PART/LOT INFORMATION. THE STEM AND ADAPTER SLEEVE ARE BEING ADDED FOR ELEVATED METAL ION LEVELS. THE COMPLAINT WAS UPDATED ON: 01/22/2015.

    Description of Event or Problem · 1

    ASR REVISION, ASR XL - LEFT. REASON FOR REVISION: HEAD AND SHELL REVISION. PAIN, ACETABULAR LOOSENING AND LYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609403 ASR UNI FEMORAL IMPL SIZE 47 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD.-8010379 2195724

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention