BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 41

    MDR report key: 4137093 · Received October 2, 2014

    Report

    Report Number
    1818910-2014-29347
    Event Type
    Injury
    Date Received
    October 2, 2014
    Date of Event
    July 17, 2007
    Report Date
    September 16, 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. (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.

    Description of Event or Problem · 1

    ASR REVISION, ASR XL- RIGHT, REASON(S) FOR REVISION: PAIN, FEMORAL NECK FRACTURE (BEYOND 3 MONTHS POST OP). QUERIED IMPLANT AND EXPLANT DATES AS ALL PRODUCTS (BARING THE CUP) WERE PRODUCED AFTER STATED IMPLANT DATE - (B)(6) 2014. REC'D CONFIRMATION (B)(4) 2014 - PATIENT IS RESURFACING TO XL. INITIAL RESURFACING SURGERY OCCURED 17 MAR 2004 WITH THE FOLLOWING PRODUCTS BEING IMPLANTED: 9998-04-146 ¿ 1143073 (CUP); 9998-03-441 ¿ 1172008 (HEAD). THE HEAD WAS THEN REMOVED (WITH THE CUP REMAINING IN SITU) ON (B)(6) 2007 AND REPLACED BY THE XL SYSTEM WITH THE FOLLOWING PRODUCTS: 9998-04-146 ¿ 1143073 (CUP) LEFT IN SITU; 9998-90-141 ¿ 1885180 (HEAD); 3L92499 ¿ 2353835 (STEM); 9998-00-102 ¿ 2398207 (TAPER SLEEVE). HOWEVER, THESE PRODUCTS HAVE NOT BEEN CONFIRMED AS REVISED YET. I HAVE THEREFORE QUERIED THE FILE HANDLER AGAIN FOR CONFIRMATION OF THIS REVISION. THEREFORE I WILL JUST LEAVE THE HEAD ON THIS COM AS IT IS THE ONLY PRODUCT THAT HAS BEEN CONFIRMED AS REMOVED. IF THE OTHER PRODUCTS ARE CONFIRMED AS REVISED I WILL ADD THEM TO ANOTHER COM AND CROSS REFERENCE IT TO THIS COM UPDATE (B)(4) 2014 - FILE HANDLER HAS REPLY THAT ALL XL PRODUCTS REMAIN IN SITU IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616562 DEPUY ASR XL FEM IMP SIZE 41 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD. 8010379 1885180

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention