BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 53

    MDR report key: 3946090 · Received July 21, 2014

    Report

    Report Number
    1818910-2014-23806
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    November 6, 2012
    Report Date
    August 12, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KXA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. 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. (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.

    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 THIS CASE CLOSED TO CAPA.

    Description of Event or Problem · 1

    ASR REVISION, ASR XL- RIGHT, REASON(S) FOR REVISION: ELEVATED METAL ION LEVELS. QUERIED WHICH COMPONENT CAME FOR WHICH HIP. BI-LATERAL - SEE (B)(4) FOR LEFT HIP.

    Description of Event or Problem · 1

    ASR REVISION, ASR XL- RIGHT, REASON(S) FOR REVISION: ELEVATED METAL ION LEVELS. QUERIED WHICH COMPONENT CAME FOR WHICH HIP - (B)(4). BI-LATERAL - SEE COM (B)(4) FOR LEFT HIP. UPDATE - 14 AUG 2014 - MARKED AS LEGAL, ATTACHED (B)(6) ALERT, ADDED KID NUMBER AND ADDED SURGEON AND HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424999 DEPUY ASR XL FEM IMP SIZE 53 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD. 8010379 2215574

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention