BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 51

    MDR report key: 2830118 · Received November 13, 2012

    Report

    Report Number
    1818910-2012-25142
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    July 11, 2012
    Report Date
    April 23, 2014
    Manufacturer
    DEPUY INTERNATIONAL
    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

    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

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

    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.

    Description of Event or Problem · 1

    ADDITIONAL REASONS FOR REVISION: COMPONENT LOOSENING AND ALVAL.

    Description of Event or Problem · 1

    ASR REVISION; ASR XL ACETABULAR SYSTEM - LEFT; REASON FOR REVISION: PAIN.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEMS) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - ASR REVISION, ASR XL ACETABULAR SYSTEM - LEFT, REASON(S) FOR REVISION: THE FEMORAL COMPONENT LOOSENED, PAIN ALVAL, INFORMATION ADDED: THE FEMORAL COMPONENT LOOSENED. UPDATE RECEIVED: 10TH APRIL 2014 - AMENDED IMPLANT DATE: (B)(6) 2006, FILLED MAPPED TO MW FIELDS, ADDED STEM, CREATED 1ST REQUEST FOR FURTHER INFORMATION ACTION ACTIVITY AND CLOSED IT AND CREATED 2ND REQUEST ACTION ACTIVITY FOR FURTHER INFORMATION. RE-OPENED: (B)(4) 2014 - SENT 2ND REQUEST FOR COMPONENT LOOSENING AND ATTACHED TO 2ND REQUEST FOR FURTHER INFORMATION ACTION ACTIVITY AND CLOSED THIS AND CREATED 3RD REQUEST FOR FURTHER INFORMATION ACTION ACTIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR XL FEM IMP SIZE 51 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL 2194756

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention