BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR IMPLANT 54

    MDR report key: 2980165 · Received February 27, 2013

    Report

    Report Number
    1818910-2013-02661
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 13, 2013
    Report Date
    May 14, 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
    UK
    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

    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 HIP RESURFACING SYSTEM - RIGHT HIP; REASON FOR REVISION: ALVAL/SOFT TISSUE REACTION.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) (B)(4). REASON FOR ORIGINAL COMPLAINT: ASR REVISION, ASR HIP RESURFACING SYSTEM - RIGHT, REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. UPDATE RECEIVED: 14TH MAY 2014 - ADDED LIRC REFERENCE NUMBER, ADDED PATIENT DATE OF BIRTH, ADDED PATIENT INFORMATION: PATIENT ACTIVITY LEVEL PRIOR TO EVENT: CLICKING HIP AND TYPE OF PATIENT ACTIVITY: WALKING TIME DECREASED AND ADDED SURGEON TITLE: PROF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83983 ASR ACETABULAR IMPLANT 54 ASR TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL LTD. 8010379 1931539

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention