BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 49

    MDR report key: 3013265 · Received March 20, 2013

    Report

    Report Number
    1818910-2013-03546
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    January 21, 2014
    Report Date
    December 17, 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
    NZ
    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

    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; RIGHT; ASR XL; REASON(S) FOR REVISION: 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 RECOMMENDED, RIGHT, ASR XL, REASON(S) FOR REVISION: UNKNOWN. UPDATE: ADDED AND AMENDED PRODUCTS AS NECESSARY. RECEIVED: AUGUST 16TH 2012. UPDATE - RECEIVED 8 MARCH 2013 REVISION DATE, SURGEON NAME, REASON FOR REVISION REASON FOR REVISION: ALVAL / SOFT TISSUE REACTION. UPDATE - ADDITIONAL REASON FOR REVISION (COMP LOOSENING QUERYING) ADDITIONAL HOSPITAL, ADDITIONAL SURGEON, AMENDED REVISION DATE. TAKEN FROM CLAIMSUITE DATED 17TH DECEMBER 2014. REASON(S) FOR REVISION: COMPONENT LOOSENING (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115655 DEPUY ASR XL FEM IMP SIZE 49 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD. 8010379 2545531

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention