BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 54

    MDR report key: 4860777 · Received June 22, 2015

    Report

    Report Number
    1818910-2015-24078
    Event Type
    Injury
    Date Received
    June 22, 2015
    Date of Event
    June 19, 2015
    Report Date
    June 19, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE US UNDER A DIFFERENT PART NUMBER. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. 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. WWCAPA (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

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER DINT (B)(4). REASON FOR ORIGINAL COMPLAINT: ASR REVISION TO TAKE PLACE ON (B)(6) 2011, ASR XL ACETABULAR SYSTEM, REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. UPDATE: (B)(6) 2015 - UPDATED REASON FOR REVISION TO INCLUDE PAIN. UPDATED HIP SIDE AS RIGHT HIP. UPDATED SURGEON'S NAME AND FILE HANDLER'S NAME. ADDED MANUFACTURE AND EXPIRY DATES FOR PRODUCTS, ADDED DUMMY STEM AND SLEEVE, QUERYING STEM AND SLEEVE DETAILS. TAKEN FROM CLAIMSUITE UPDATE (B)(6) 2015. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404252 TOTAL ASR ACET IMP SIZE 54 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 1852207

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention