BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 45

    MDR report key: 3120717 · Received May 20, 2013

    Report

    Report Number
    1818910-2013-05850
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    August 11, 2010
    Report Date
    December 2, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    KXA
    Removal / Correction Number
    Z- 1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    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, RESURFACING, REASON FOR REVISION: UNKNOWN.

    Description of Event or Problem · 1

    UPDATE 2 DEC. 2015: UPDATED REASONS FOR REVISION TO INCLUDE PAIN, ALVAL / SOFT TISSUE REACTION, FEMORAL NECK FRACTURE (BEYOND 3 MONTHS) AND NOISE. ADDED MANUFACTURE AND EXPIRY DATES TO PRODUCTS, UPDATED FILE HANDLER DETAILS. TAKEN FROM (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221797 TOTAL ASR FEM IMP SIZE 45 ASR TOTAL HIP REPLACEMENT KXA DEPUY INTERNATIONAL LTD - 8010379 1173849

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention