BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 47

    MDR report key: 3982395 · Received August 6, 2014

    Report

    Report Number
    1818910-2014-25097
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    May 12, 2013
    Report Date
    August 25, 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
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: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. (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

    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

    ASR REVISION HIP SIDE UNKNOWN XL REASON FOR REVISION : UNKNOWN THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    ASR REVISION.HIP SIDE UNKNOWN.XL.REASON FOR REVISON : UNKNOWN.

    Description of Event or Problem · 1

    UPDATE (B)(6) 2015: UPDATED WITH CRAWFORDS REF. (B)(4), ADDED PATIENT NAME, AND DATE OF BIRTH. AMENDED DOI TO (B)(6) 2006. ADDED REASONS FOR REVISION TO INCLUDE, PAIN, ALVAL / SOFT TISSUE REACTION, METALLOSIS AND METAL IONS. ADDED SURGEONS' NAMES. ADDED EXPIRY DATES FOR PRODUCTS. TAKEN FROM IAN (B)(6) AND UPDATED LEGAL CLAIM ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460652 DEPUY ASR XL FEM IMP SIZE 47 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD. 8010379 2073850

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention