BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 51

    MDR report key: 3218200 · Received July 10, 2013

    Report

    Report Number
    1818910-2013-20945
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    August 13, 2013
    Report Date
    April 28, 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
    AS
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    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 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.

    Description of Event or Problem · 1

    ASR REVISION; ASR XL- LEFT; REASON(S) FOR REVISION: UNKNOWN.

    Description of Event or Problem · 1

    ASR REVISION. ASR XL- LEFT**. REASON(S) FOR REVISION: UNKNOWN. UPDATE RECEIVED: 22ND JULY 2013 - ADDED LOT NUMBER TO CUP: 1877479. UPDATE RECEIVED: AMENDED SIDE HIP: ** RIGHT. UPDATE - ADDED HOSPITAL AND REVISION DATE TAKEN FROM CLAIMSUITE DATED 18TH SEPTEMBER 2013. 28 APRIL 2015 - UPDATE - RCVD UPDATE CLAIMSUITE AND OP NOTES, ADDED PATIENT NAME, DOB, GENDER, ADDED STEM DETAILS AND MANU AND EXP DATES OF PRODUCTS, ADDED REASON FOR REVISION: COBALT/CHROMIUM LEVELS ARE HIGH, LOOSENING OF ACETABULAR AND FEMORAL COMPONENT, PSEUDO TUMOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317013 DEPUY ASR XL FEM IMP SIZE 51 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD. 8010379 1953675

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention