BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 47

    MDR report key: 3864894 · Received June 10, 2014

    Report

    Report Number
    1818910-2014-20635
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    July 4, 2012
    Report Date
    May 29, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KXA
    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. NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE US UNDER A DIFFERENT PART NUMBER. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> REVISION OF THE DEVICE HAS BEEN REPORTED AND THERE WAS NO ALLEGATION THAT THE DEVICE WAS A CONTRIBUTOR TO THIS EVENT. NO EXPLANTED DEVICES HAVE BEEN RECEIVED IN RESPECT OF THIS PATIENT FOR ANALYSIS. MANUFACTURING RECORDS HAVE BEEN REVIEWED AND THE DEVICE(S) MET SPECIFICATION PRIOR TO PLACING ON THE MARKET. IF FURTHER INFORMATION IS RECEIVED INDICATING THAT THE DEVICE WAS A CONTRIBUTOR OR THERE IS AN ALLEGED DEFICIENCY OF THE DEVICE THEN THIS EVENT WILL BE RE-OPENED FOR EVALUATION. DEVICE HISTORY LOT ==> A REVIEW OF MANUFACTURING RECORDS OF LOT 2191893 DID NOT IDENTIFY ANY ANOMALIES. (B)(4) MANUFACTURED AND PLACED INTO STOCK ON 17 JUL 2006. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    ASR REVISION, RIGHT, ASR XL, REASON(S) FOR REVISION: PAIN / IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338653 DEPUY ASR XL FEM IMP SIZE 47 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD. 8010379 2191893

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R