BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR IMPLANT 52

    MDR report key: 3120326 · Received May 20, 2013

    Report

    Report Number
    1818910-2013-05836
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    May 17, 2009
    Report Date
    May 8, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    Removal / Correction Number
    Z- 1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    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 RIGHT; REASON(S) FOR REVISION: ACETABULAR COMPONENT LOOSENING.

    Description of Event or Problem · 1

    NEW (B)(6) RECORD CREATED IN ORDER TO UPDATE (B)(6) (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - ASR REVISION ASR XL RIGHT. REASON(S) FOR REVISION: COMPONENT LOOSENING (CUP). UPDATE RECEIVED: 8TH MAY 2014 - ADDED HOSPITAL: (B)(6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221768 ASR ACETABULAR IMPLANT 52 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 2164120

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention