BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMA HI OFFSET R SZ 3

    MDR report key: 3991402 · Received August 8, 2014

    Report

    Report Number
    1818910-2014-25265
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 1, 2012
    Report Date
    October 13, 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE US 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. (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

    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

    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 - RIGHT. REASON(S) FOR REVISION: PAIN. UPDATE 1 AUGUST 2014 - MARKED AS LEGAL, UPDATED DOR, ADDED KID AND ADDED STEM. UPDATE 13 OCT 2014 - ATTACHED LEGAL LETTER, ADDED PATIENT GENDER, NAME AND DOB. ADDED FLUID AND ELEVATED COCR LEVELS AS REASONS FOR REVISION. ADDED EXPIRY DATES TO ALL PRODUCTS.

    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 - RIGHT; REASON(S) FOR REVISION: PAIN. UPDATE (B)(4) 2014 - MARKED AS LEGAL, UPDATED DOR, ADDED KID AND ADDED STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468817 PROXIMA HI OFFSET R SZ 3 HIP FEMORAL STEM/SLEEVE KWA DEPUY INTERNATIONAL LTD. 8010379 2170547

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention