BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 56

    MDR report key: 2935866 · Received January 30, 2013

    Report

    Report Number
    1818910-2013-01833
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 15, 2013
    Report Date
    May 21, 2014
    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
    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

    DEPUY STILL CONSIDERS THE 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.

    Description of Event or Problem · 1

    ASR REVISION; ASR XL SYSTEM - LEFT HIP; REASONS FOR REVISION: HIGH METAL IONS; METALLOSIS.

    Description of Event or Problem · 1

    ADDITIONAL REASON FOR REVISION: PAIN.

    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, LEFT HIP, ASR XL SYSTEM, REASON FOR REVISION: HIGH METAL IONS, METALLOSIS. UPDATE RECEIVED (B)(6) 2013. ADDITIONAL REASON FOR REVISION, FORM 57 ADDED. ADDITIONAL REASON(S) FOR REVISION: PAIN. UPDATE RECEIVED: (B)(6) 2014 - ATTACHED LEGAL LETTER, MARKED AS LEGAL, FILLED MAPPED TO MW FIELDS, ADDED PATIENT NAME, ADDED PATIENT INITIALS, ADDED PATIENT GENDER, ADDED PATIENT DATE OF BIRTH, ADDED PATIENT AGE AND ADDED HOSPITALS: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41273 TOTAL ASR ACET IMP SIZE 56 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 2765064

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention