BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 54

    MDR report key: 2970093 · Received February 20, 2013

    Report

    Report Number
    1818910-2013-02585
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    February 14, 2013
    Report Date
    July 29, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    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

    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

    ADDITIONAL NARRATIVE: 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 ACETABULAR SYSTEM - RIGHT HIP; REASON FOR REVISION: HIGH METAL ION LEVELS IN THE BLOOD OF THE PATIENT.

    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; HIP(S) TO BE REVISED: RIGHT. TYPE OF HIP REPLACEMENT PRODUCT: ASR XL ACETABULAR SYSTEM; ASR XL TAPER SLEEVE ADAPTOR REASON(S) FOR REVISION: HIGH METAL ION LEVEL IN BLOOD. UPDATE - MARKED AS LEGAL, ADDED KID NUMBER AND ADDITIONAL HOSPITAL. TAKEN FROM CLAIMSUITE DATED 29TH JULY 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73863 TOTAL ASR ACET IMP SIZE 54 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 2584950

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention