BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 43

    MDR report key: 3070190 · Received April 22, 2013

    Report

    Report Number
    1818910-2013-04959
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    May 6, 2009
    Report Date
    April 11, 2013
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KXA
    Removal / Correction Number
    Z- 1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT
    Health Professional
    N

    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.

    Description of Event or Problem · 1

    ASR REVISION.ASR HIP RESURFACING - LEFT.REASON(S) FOR REVISION: DISLOCATIONS (NOT ARISING FROM TRAUMATIC EVENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172284 TOTAL ASR FEM IMP SIZE 43 ASR TOTAL HIP REPLACEMENT KXA DEPUY INTERNATIONAL LTD. 8010379 1852067

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention