BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 3094056 · Received May 6, 2013

    Report

    Report Number
    1818910-2013-05366
    Event Type
    Injury
    Date Received
    May 6, 2013
    Report Date
    April 29, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS CONSIDERED 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. (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

    (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.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD PAIN, DISCOMFORT AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT AFTER ASR HIP IMPLANT.

    Description of Event or Problem · 1

    UPDATE (B)(6) 2016 SUPPLEMENTAL RECEIVED. PART AND LOT INFORMATION HAS BEEN PROVIDED. ADDING THE SLEEVE AND FEMORAL STEM FOR ELEVATED IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197424 ASR UNI FEMORAL IMPL SIZE 45 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2702784

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention