BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARGE MOD HEAD ADAPT 12/14 +5

    MDR report key: 4212194 · Received October 30, 2014

    Report

    Report Number
    1818910-2014-30912
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    April 26, 2010
    Report Date
    October 28, 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
    SZ
    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 U.S 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.

    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: LEFT; TYPE OF HIP REPLACEMENT PRODUCT: ASR XL; REASON(S) FOR REVISION: PAIN. UPDATE - ADDED STEM AND SLEEVE TAKEN FROM CLAIMSUITE DATED 13TH DECEMBER 2013. UPDATE - ADDED ADDITIONAL HOSPITAL, FILED OUT MW FIELDS, FILED IN MANUFACTURING AND EXPIRY DATES. TAKEN FROM CLAIMSUITE DATED 28TH OCTOBER 2014. ADDITIONAL HOSPITAL - (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695064 LARGE MOD HEAD ADAPT 12/14 +5 HIP FEMORAL STEM/SLEEVE KWA DEPUY INTERNATIONAL LTD. 8010379 2195170

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention