BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARGE MOD HEAD ADAPT 12/14 +5

    MDR report key: 3043203 · Received April 9, 2013

    Report

    Report Number
    1818910-2013-04688
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    March 18, 2013
    Report Date
    September 30, 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
    AS
    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. 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

    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.

    Description of Event or Problem · 1

    ASR REVISION; ASR XL - RIGHT; REASON FOR REVISION: UNKNOWN.

    Description of Event or Problem · 1

    (B)(6) 2015 - UPDATE - RCVD UPDATED CLAIMSUITE - RCVD STEM DETAILS, ADDED MANU AND EXP DATES, PATIENT IS BILATERAL - FOR LEFT HIP SEE (B)(4)- KF (B)(6) 2015. (B)(6) 2015 - RCVD EMAIL TO CONF CORRECT IMPLANT DATE, AMEND STEM WITH LOT NUMBER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146969 LARGE MOD HEAD ADAPT 12/14 +5 HIP FEMORAL STEM/SLEEVE KWA DEPUY INTERNATIONAL LTD - 8010379 1955000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention