BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTER SLEEVES 12/14 +2

    MDR report key: 4242130 · Received November 10, 2014

    Report

    Report Number
    1818910-2014-31497
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    August 18, 2014
    Report Date
    October 15, 2014
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    PMA / PMN Number
    P3/20/13
    Removal / Correction Number
    DEPUY ORTHOPAEDICS, INC.
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    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. (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 PAIN, STIFFNESS, WEAKNESS, AND ELEVATED METAL ION LEVELS. UPDATE REC¿D 9/3/2014 - MEDICAL RECORDS RECEIVED. UPON REVISION, OSTEOPHYTES AND A SCARRED LABRUM WERE NOTED. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION. THIS COMPLAINT WAS UPDATED ON: 09/23/2014. UPDATE REC¿D 10/15/2014 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PAART/LOT INFORMATION FROM PATIENT STICKER SHEET. THE STEM AND SLEEVE ARE BEING ADDED TO THE COMPLAINT. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 11/10/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722570 ADAPTER SLEEVES 12/14 +2 HIP FEMORAL STEM/SLEEVE KWA DEPUY INTL., LTD. - 8010379 2587238

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention