BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMA HI OFFSET R SZ 4

    MDR report key: 5130938 · Received October 6, 2015

    Report

    Report Number
    1818910-2015-32157
    Event Type
    Injury
    Date Received
    October 6, 2015
    Date of Event
    August 3, 2011
    Report Date
    October 7, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    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. 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.

    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 DINT (B)(4) REASON FOR ORIGINAL COMPLAINT - ASR REVISION. ASR XL ACETABULAR SYSTEM (RIGHT). REASON(S) FOR REVISION: PAIN. UPDATE : PRODUCTS (STEM & SLEEVE) ADDED AS PER UPDATE EMAIL 16 JAN 2013. UPDATE - UPDATED TO MARK AS LEGAL AND ATTACH (B)(4) EMAIL DATED 6TH JAN 2014. UPDATE - FILLED OUT ALL MW FIELDS, AMENDED LOT NUMBER FOR HEAD, ADDED EXPIRY AND MANUFACTURING DATE FOR CUP, ADDED EXPIRY DATE FOR HEAD. TAKEN FROM EMAIL DATED 29TH SEPT 2015. - (B)(4) 2015 LOT NUMBER FOR HEAD - 2890577.

    Description of Event or Problem · 1

    UPDATE - RECEIVED STEM AND SLEEVE DETAILS, HOSPITAL AND SURGEON. TAKEN FROM UPDATE EMAIL DATED 7TH OCT 15.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660810 PROXIMA HI OFFSET R SZ 4 HIP FEMORAL STEM/SLEEVE KWA DEPUY INTERNATIONAL LTD - 8010379 3087684

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention