BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 46

    MDR report key: 3354566 · Received September 18, 2013

    Report

    Report Number
    1818910-2013-27702
    Event Type
    Injury
    Date Received
    September 18, 2013
    Date of Event
    October 18, 2011
    Report Date
    March 22, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD.
    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

    NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE U.S. 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

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    ASR REVISION; ASR RESURFACING - LEFT; REASON(S) FOR REVISION: PAIN. SCF FORM ADDED. BILATERAL - SEE COM 022074 FOR RIGHT HIP.

    Description of Event or Problem · 1

    ASR REVISION, ASR RESURFACING - LEFT, REASON(S) FOR REVISION: PAIN. SCF FORM ADDED. BILATERAL - SEE (B)(4) FOR RIGHT HIP. UPDATE RECEIVED 22ND MARCH 2014 - ADDITIONAL HOSPITAL ADDED AND NEW FIELDS COMPLETED. REASON FOR REVISION AMENDED: REASON(S) FOR REVISION: PAIN, METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469382 TOTAL ASR FEM IMP SIZE 46 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD. 2717072

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention