BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 47

    MDR report key: 2915190 · Received January 15, 2013

    Report

    Report Number
    1818910-2013-00919
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    July 25, 2012
    Report Date
    March 11, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD.
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    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. (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

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL 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.

    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 XL SYSTEM - RIGHT HIP; REASON FOR REVISION: UNKNOWN.

    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. RIGHT HIP. ASR XL SYSTEM. REASON FOR REVISION UNKNOWN, SEE BELOW. UPDATE RECEIVED MAY 24TH, 2013. HOSPITAL, ACETABULAR CUP DETAILS ADDED. LOT NUMBERS ADDED. REVISION DATE AMENDED. UPDATE RECEIVED JUNE 4TH, 2013. REASONS FOR REVISION, STEM, ADDITIONAL HOSPITAL, PATIENT ID ADDED. REASON(S) FOR REVISION: PAIN, NOISE, ELEVATED COBALT AND CHROMIUM LEVELS. UPDATE 20 FEB 2015: REC'D LEGAL LETTER FROM (B)(6), COM MARKED AS LEGAL, PATIENT'S NAME, SEX AND DOB. EXP/MAN DATES FOR ALL PRODUCTS, MAN FACILITIES, COMMON/BRAND NAME, AMENDED ALL REASONS FOR REVISION, ALL MW FIELDS.

    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. RIGHT HIP. ASR XL SYSTEM. REASON FOR REVISION UNKNOWN, SEE BELOW. UPDATE RECEIVED MAY 24TH, 2013. HOSPITAL, ACETABULAR CUP DETAILS ADDED. LOT NUMBERS ADDED. REVISION DATE AMENDED. UPDATE RECEIVED JUNE 4TH, 2013. REASONS FOR REVISION, STEM, ADDITIONAL HOSPITAL, PATIENT ID ADDED. REASON(S) FOR REVISION: PAIN, NOISE, ELEVATED COBALT AND CHROMIUM LEVELS. UPDATE 20 FEB 2015: REC'D LEGAL LETTER FROM (B)(6), COM MARKED AS LEGAL, PATIENT'S NAME, SEX AND DOB. EXP/MAN DATES FOR ALL PRODUCTS, MAN FACILITIES, COMMON/BRAND NAME, AMENDED ALL REASONS FOR REVISION, ALL MW FIELDS. UPDATE 11 MAR 2015: ADDED PREVIOUSLY MISSED INFO - PATIENT'S NAME, SEX, DOB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22149 DEPUY ASR XL FEM IMP SIZE 47 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD. 1847354

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention