BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 56

    MDR report key: 3142785 · Received June 3, 2013

    Report

    Report Number
    1818910-2013-06346
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    March 25, 2013
    Report Date
    January 19, 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
    US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    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 RESURFACING - 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 RESURFACING - RIGHT, REASON(S) FOR REVISION: PAIN. UPDATE RECEIVED JUNE 6TH, 2013. ADDITIONAL REASON FOR REVISION ADDED, HOSPITAL ADDED AND IMPLANT DATE AMENDED. REASON(S) FOR REVISION: HIGH METAL ION WITH PSEUDOTUMOUR. UPDATE 19 JAN 2015 - (B)(6) ALERT REC'D, KID, MARKED AS LEGAL, IMPLANT DATE, FILLED IN ALL MAN/EXP DATES FOR PRODUCTS, MANUFACTURING FACILITIES, COMPLAINT CATEGORY, CONSTRUCT TYPE AND ALL NECESSARY MW BOXES -

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244539 TOTAL ASR ACET IMP SIZE 56 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD - 8010379 1877485

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention