BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 46

    MDR report key: 2946355 · Received February 6, 2013

    Report

    Report Number
    1818910-2013-02269
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    September 1, 2014
    Report Date
    September 24, 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
    US
    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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    ASR REVISION.ASR XL - LEFT 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) COMPLAINT NUMBER (B)(4) REASON FOR ORIGINAL COMPLAINT - ASR REVISION, ASR XL - LEFT HIP, REASON FOR REVISION UNKNOWN. UPDATE- ADDED PRODUCTS X 3, REASON FOR REVISION TAKEN FROM CLAIMSUITE DATED 31ST JAN 2013. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. UPDATE - AMENDED REVISION DATE AND ADDED ADDITIONAL HOSPITAL AND ADDITIONAL SURGEON. TAKEN FROM CLAIMSUITE DATED 24TH SEPT 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50832 DEPUY ASR XL FEM IMP SIZE 46 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD. 8010379 2180774

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention