BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 45

    MDR report key: 3200632 · Received July 1, 2013

    Report

    Report Number
    1818910-2013-20297
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    December 18, 2012
    Report Date
    May 6, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD.
    Product Code
    KXA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 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

    ASR REVISION, ASR XL ACETABULAR SYSTEM - RIGHT, REASON(S) FOR REVISION: COMPONENT LOOSENING: ACETABULAR CUP.

    Description of Event or Problem · 1

    ASR REVISION ASR XL ACETABULAR SYSTEM - RIGHT REASON(S) FOR REVISION: COMPONENT LOOSENING: ACETABULAR CUP. UPDATE RECEIVED: 6TH MAY 2014 - CROSS REFERENCED, ATTACHED DUPLICATE KENNEDYS DOCUMENT, FILLED MAPPED TO MW FIELDS, MARKED AS LEGAL, ADDED KENNEDYS REFERENCE NUMBER, AMENDED IMPLANT DATE: (B)(6) 2008, ADVISED NON-DEPUY STEM, ADDED HOSPITAL: (B)(6), CREATED 1ST FURTHER INFORMATION REQUEST ACTION ACTIVITY, ATTACHED QUERY DOCUMENT AND CLOSE AND CREATED 2ND FURTHER INFORMATION REQUEST ACTION ACTIVITY,. BI-LATERAL PATIENT - PLEASE SEE (B)(4) FOR LEFT SIDE REVISION. THIS COM IS TO BE CLOSED TO CAPA DUE TO THE REASONS FOR REVISION FALLING WITHIN THE CAPA REMIT AND OFF LABEL USE OF A COMPETITOR STEM UPDATE RECEIVED: 6TH MAY 2014 - AMENDED REVISION DATE: (B)(6) 2014 AND ADVISED FILE HANDLER HAS CONFIRMED CUP LOOSENING IS NOT THE REASON FOR REVISION. THE CORRECT REVISION REASON IS PAIN - SEE ADDITIONAL INFORMATION FOR MORE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299550 DEPUY ASR XL FEM IMP SIZE 45 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD. 2580785

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention