BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 45

    MDR report key: 2842957 · Received November 21, 2012

    Report

    Report Number
    1818910-2012-25260
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    December 13, 2009
    Report Date
    November 4, 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

    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.

    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.

    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, ASR XL - RIGHT, REASON(S) FOR REVISION: INCREASED ION LEVELS. UPDATE - ADDED ADDITIONAL REASONS FOR REVISION. TAKEN FROM CLAIMSUITE DATED 5TH NOV 2014 AND SCF DATED 4TH NOV 2014. REASON (S) FOR REVISION : PAIN, ALVAL/SOFT TISSUE REACTION, COMPONENT LOOSENING (QUERYING). UPDATE - RECEIVED EMAIL FROM FILE HANDLER DATED 17TH NOV 2014 CONFIRMING THE CUP BECAME LOOSE.

    Description of Event or Problem · 1

    ASR REVISION; ASR XL - RIGHT; REASON FOR REVISION: INCREASED METAL ION LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR XL FEM IMP SIZE 45 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD. 8010379 2032067

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention