BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 41

    MDR report key: 2761088 · Received September 26, 2012

    Report

    Report Number
    1818910-2012-75399
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    August 27, 2012
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4) USED TO CAPTURE THE BLOOD HEAVY METAL.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD PAIN AND INHIBITIONS OF ABILITY TO WALK AND MOVE AFTER ASR HIP IMPLANT. **UPDATE** 9/28/ 2012 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/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

    LITIGATION ALLEGES PATIENT HAD PAIN AND INHIBITIONS OF ABILITY TO WALK AND MOVE AFTER ASR HIP IMPLANT.

    Description of Event or Problem · 1

    AFTER REVIEW OF MEDICAL RECORDS, THERE WERE NO REVISION REPORTED. HOWEVER, CLINICAL VISIT ALLEGES ARTHRALGIA, DISTRESS, ELEVATED COBALT LEVEL, HEARING LOSS, CHRONICALLY ANEMIC, PSEUDOCYST FORMATION AND PULMONARY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 41 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL LTD - 8010379 2064723

    Patients

    Seq Age Sex Outcome Treatment
    1 Other