BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 41

    MDR report key: 4171775 · Received October 15, 2014

    Report

    Report Number
    1818910-2014-29962
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    March 27, 2014
    Report Date
    September 29, 2014
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 (B)(4) 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).

    Description of Event or Problem · 1

    SALES REP REPORTED REVISION SURGERY. PATIENT HAS ASR IN AND WANTED IT OUT. UPDATE REC¿D (B)(4) 2014 - LEGAL CLAIM WAS RECEIVED, WHICH IDENTIFIED DOB INFORMATION. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: (B)(4) 2014 UPDATE REC'D (B)(4) 2014- LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES PAIN, INJURY, AND ELEVATED METAL ION LEVELS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: (B)(4) 2014

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654742 ASR UNI FEMORAL IMPL SIZE 41 HIP FEMORAL HEAD KWA DEPUY INTL., LTD. - 8010379 2341523

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention