BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 49

    MDR report key: 2822350 · Received November 7, 2012

    Report

    Report Number
    1818910-2012-24450
    Event Type
    Injury
    Date Received
    November 7, 2012
    Report Date
    August 13, 2015
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z- 1749/1816-2011
    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. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. (B)(4).

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE, THE PATIENT SUFFERS FROM PAIN, ELEVATED METAL ION LEVELS, DISCOMFORT, DIFFICULTY WALKING, AND A POPPING AND GRINDING NOISE.

    Description of Event or Problem · 1

    UPDATE REC'D 8/13/2015 & 8/19/2015 - LITIGATION PAPERS RECEIVED. NO NEW ADDITIONAL INFORMATION RECEIVED WILL CHANGE THE MDR DECISION. UPDATE REC'D 8/25/2015 - PLAINTIFF PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH PROVIDED DOI AND PRODUCT/LOT CODES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 49 HIP OTHER IMPLANT KWA DEPUY INTERNATIONAL 2771843

    Patients

    Seq Age Sex Outcome Treatment
    1 Other