BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 50

    MDR report key: 3151001 · Received June 6, 2013

    Report

    Report Number
    1818910-2013-18336
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    January 24, 2014
    Report Date
    January 24, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD.
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PATIENT

    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. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    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. (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

    ASR REVISION. ASR XL - UNKNOWN WHICH SIDE HIP. REASON(S) FOR REVISION: PAIN. IMPLANT TOOK PLACE IN 2006, NO SPECIFIC DATE GIVEN. UPDATE RECEIVED: (B)(6) 2014 - ADDED IMPLANT DATE: (B)(6) 2007, ADDED SURGEON: (B)(6), ADDED HOSPITAL: (B)(6). (B)(4) REF NUMBER, ADDED SIDE HIP: LEFT, ADDED FURTHER REASON(S) FOR REVISION: METALLOSIS AND HIGH METAL ION LEVEL IN BLOOD AND ADDED PRODUCTS: STEM AND TAPER SLEEVE.

    Description of Event or Problem · 1

    ASR REVISION. ASR XL - UNKNOWN WHICH SIDE HIP. REASON(S) FOR REVISION: PAIN. IMPLANT TOOK PLACE IN 2006, NO SPECIFIC DATE GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249958 TOTAL ASR ACET IMP SIZE 50 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 2203831

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention