BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 45

    MDR report key: 2921381 · Received January 17, 2013

    Report

    Report Number
    1818910-2013-00993
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 10, 2012
    Report Date
    July 3, 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
    US
    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. (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: DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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

    DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    ASR REVISION; ASR XL - LEFT HIP; REASON FOR REVISION: PAIN.

    Description of Event or Problem · 1

    UPDATE 3 JUL 2015: REC'D KENNEDYS ECLAIMS, ADDED KID, ADDITIONAL HOSPITAL AND SURGEON, CHANGED HIP SIDE, EXP DATE FOR CUP AND HEAD.

    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 - LEFT. REASON(S) FOR REVISION: PAIN. UPDATE RECEIVED: 30TH JUNE 2014 - ATTACHED LEGAL DOCUMENTS, ADDED PATIENTS NAME, AMENDED IMPLANT DATE: (B)(6) 2007, ADDED PATIENT GENDER, ADDED SURGEON: DR. (B)(6) AND ADDED FURTHER HOSPITAL: (B)(6).

    Description of Event or Problem · 1

    PATIENT UNDERWENT A REVISION TO ADDRESS PAIN AND ELEVATED METAL IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26136 DEPUY ASR XL FEM IMP SIZE 45 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD. 8010379 2284334

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention