BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 53

    MDR report key: 3151071 · Received June 6, 2013

    Report

    Report Number
    1818910-2013-18355
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 28, 2013
    Report Date
    October 2, 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

    ADDITIONAL NARRATIVE: 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.

    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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA

    Description of Event or Problem · 1

    ASR REVISION, RIGHT, ASR XL, REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION.

    Description of Event or Problem · 1

    ASR REVISION; RIGHT; ASR XL; REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. UPDATE RECEIVED (B)(4) 2014.

    Description of Event or Problem · 1

    UPDATE - AMENDED IMPLANT DATE AND ADDED ALL EXPIRY DATES. TAKEN FROM CLAIMSUITE DATED (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250524 DEPUY ASR XL FEM IMP SIZE 53 HIP FEMORAL HEAD KWA DEPUY INTL., LTD. - 8010379 2556014

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention