BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASR ACETABULAR IMPLANT 60

    MDR report key: 3093496 · Received May 6, 2013

    Report

    Report Number
    1818910-2013-05254
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    March 10, 2013
    Report Date
    April 25, 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
    EI
    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 XL - LEFT,REASON(S) FOR REVISION: PAIN, NOISE AND ALVAL / SOFT TISSUE REACTION.

    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 TO TAKE PLACE ON (B)(6) 2011, ASR HIP RESURFACING - RIGHT HIP, REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION, PAIN, COMPONENT MALALIGNMENT. UPDATE: ADDITIONAL HOSPITAL, SURGEON, REASONS FOR REVISION AND CORRECTED IMPLANT DATE AS PER COMPLAINTS REPORT RECEIVED 18 NOV 2011, VERIFIED BY FORM 57 PREVIOUSLY ATTACHED . UPDATE- UPDATED ORIGINAL SURGERY DATE TAKEN FROM CLAIMSUITE DATED 17TH JAN 2013. UPDATE - MARKED CLAIM AS LEGAL. TAKEN FROM (B)(6) EMAIL DATED 25TH APRIL 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197313 ASR ACETABULAR IMPLANT 60 ASR TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL LTD. 8010379 2823059

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention