BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 50

    MDR report key: 2884674 · Received December 24, 2012

    Report

    Report Number
    1818910-2012-29073
    Event Type
    Injury
    Date Received
    December 24, 2012
    Date of Event
    August 8, 2010
    Report Date
    September 1, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. 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. (B)(4). SEE SECTION FOR PRODUCT INFORMATION RECEIVED. THIS COMPLAINT IS THE SUBJECT OF LITIGATION OR A LEGAL CLAIM AND CURRENTLY COMPLETE PRODUCT DETAIL IS NOT AVAILABLE AT THIS TIME. A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    ASR REVISION; ASR XL ACETABULAR SYSTEM - LEFT; REASON FOR REVISION: COMPONENT LOOSENING (ACETABULAR CUP).

    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 ACETABULAR SYSTEM - LEFT. REASON(S) FOR REVISION: COMPONENT LOOSENING (ACETABULAR CUP). UPDATE - MARKED AS LEGAL, ADDED KID NUMBER. TAKEN FROM KENNEDYS EMAIL DATED (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR ACET IMP SIZE 50 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention