BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 2232774 · Received August 18, 2011

    Report

    Report Number
    1818910-2011-15602
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    September 5, 2006
    Report Date
    July 19, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    UPDATE: (B)(6) 2012, PATIENT FACT SHEET FORM WAS RECEIVED WHICH IDENTIFIED PART/LOT INFORMATION. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PT HAS BEEN CAUSED TO UNDERGO EXTENSIVE PAIN AND DISCOMFORT, SUFFER FROM COMPLICATIONS THAT WERE A RESULT OF DISLOCATION OF THE HIP PROSTHESIS, AND CAUSED TO UNDERGO PAINFUL CORRECTIVE SURGERIES IN ORDER TO REMOVE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 47 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL, LTD. NA 2173216

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention