BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 54

    MDR report key: 4816765 · Received June 3, 2015

    Report

    Report Number
    1818910-2015-22611
    Event Type
    Injury
    Date Received
    June 3, 2015
    Date of Event
    January 27, 2014
    Report Date
    May 29, 2015
    Manufacturer
    DEPUY INTL., 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

    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 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 THIS INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    ASR REVISION. ASR XL- RIGHT. REASON(S) FOR REVISION: PAIN, POSSIBLE COMPONENT LOOSENING (CUP). CORRECTION ADDED 1$TH FEBRUARY, 2014. INFORMATION RECEIVED 27TH JANUARY, 2014. ADDITIONAL HOSPITAL ADDED. COMPLAINT CATEGORIES AND NEW BOXES AMENDED. COMMON NAME AND CONSTRUCT TYPE AMENDED FOR TAPER SLEEVE. UPDATE - MARKED AS LEGAL, ADDED KID NUMBER, ADDED ALL EXPIRY AND MANUFACTURING DATES. TAKEN FROM (B)(6) EMAIL DATED 29TH MAY 2015 - AB 1ST JUNE 2015. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357816 TOTAL ASR ACET IMP SIZE 54 HIP ACETABULAR CUP KWA DEPUY INTL., LTD. - 8010379 2218860

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CORAIL2 STD SIZE 12| DEPUY ASR XL FEM IMP SIZE 47| TAPER SLEEVE ADAPTER 12/14 +8