BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 49

    MDR report key: 3050024 · Received April 10, 2013

    Report

    Report Number
    1818910-2013-04706
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 10, 2013
    Report Date
    September 12, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD.
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    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 HIP; REASON FOR REVISION: PAIN.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - ASR REVISION. ASR XL- RIGHT. REASON(S) FOR REVISION: PAIN. UPDATE RECEIVED 9TH DECEMBER, 2013. STEM ADDED. BILATERAL PATIENT - SEE (B)(4) FOR OTHER HIP. UPDATE - FILED OUT MW FIELDS, SCF AND ADDED ADDITIONAL REASON FOR REVISION. TAKEN FROM SURGEON FORM DATED (B)(6) 2014. REASON FOR REVISION (S) : ALVAL/ SOFT TISSUE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151979 DEPUY ASR XL FEM IMP SIZE 49 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD. 2105508

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention