BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 41

    MDR report key: 3296522 · Received August 19, 2013

    Report

    Report Number
    1818910-2013-24341
    Event Type
    Injury
    Date Received
    August 19, 2013
    Date of Event
    May 11, 2011
    Report Date
    August 26, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD.
    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

    NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE U.S. 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

    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

    PATIENT HAS BEEN REVISED TO ADDRESS IMPLANT LOOSENING.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - ASR REVISION RECOMMENDED. ASR XL ACETABULAR SYSTEM (RIGHT) AND ASR XL ACETABULAR SYSTEM (LEFT) - BI-LITERAL. UPDATE RECEIVED 29 JULY 2013 - DOR, PRODUCT CODES, LOT NUMBERS, REASON FOR REVISION. UPDATE RECEIVED 26 AUGUST 2014. CORRECT REVISION DATE ATTRIBUTED TO LEFT HIP. CORRECT REVISION REASONS ATTRIBUTED TO THE RIGHT HIP. CORRECT HIP SIDE ATTRIBUTED TO PRODUCTS. REVISION DATE ADDED FOR THE RIGHT HIP. REASON FOR REVISION ADDED FOR THE LEFT HIP. NEW FIELDS COMPLETED. LEFT HIP REVISION: (B)(6) 2011. 999800206 / 1221341; 999804146 / 1203277; 999890141 / 1885180. REASON(S) FOR REVISION: COMPONENT LOOSENING (CUP). RIGHT HIP REVISION: (B)(6) 2011. 999890141 / 1929077; 999800206 / 1221341; 999804146 / 1839873. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. QUERY CONFIRMATION RECEIVED 1ST SEPTEMBER 2014. COMPONENT LOOSENED CONFIRMED TO BE THE CUP. IMPLANT DATES CONFIRMED. LEFT HIP IMPLANT DATE: (B)(6) 2006. RIGHT HIP IMPLANT DATE: (B)(6) 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400492 DEPUY ASR XL FEM IMP SIZE 41 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD. 1885180

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention