BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 47

    MDR report key: 3844373 · Received June 2, 2014

    Report

    Report Number
    1818910-2014-19943
    Event Type
    Injury
    Date Received
    June 2, 2014
    Report Date
    June 5, 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
    US
    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. 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

    DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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

    UPDATE 10 JULY 2015: ADDED LOT NUMBERS, MANUFACTURE AND EXPIRY DATES FOR STEM AND SLEEVE, UPDATED REASONS FOR REVISION TO INCLUDE PAIN AND OSTEOLYSIS, UPDATED FILE HANDLER DETAILS, TAKEN FROM SCF (B)(6) 2015 AND CLAIMSUITE UPDATE (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    (B)(4). FOLLOWING A DEBRIS DISEASE DUE TO USURY THE PATIENT WAS SUBJECTED TO RE.-INTERVENTION. ASR REVISION RECOMMENDED, ASR XL - RIGHT. REASON(S) FOR REVISION: SINCE THE DISEASE BY WEAR DEBRIS HAS CERTAIN PROSTHETIC AND IMPLANT FAILURE DUE TO DEFECT IN THE PRODUCT.

    Description of Event or Problem · 1

    (B)(4). FOLLOWING A DEBRIS DISEASE DUE TO USURY THE PATIENT WAS SUBJECTED TO RE.-INTERVENTION. ASR REVISION RECOMMENDED. ASR XL - RIGHT. REASON(S) FOR REVISION: SINCE THE DISEASE BY WEAR DEBRIS HAS CERTAIN PROSTHETIC AND IMPLANT FAILURE DUE TO DEFECT IN THE PRODUCT. UPDATE 31 OCT 2014 - (B)(4), DATE OF REVISION - (B)(6) 2012, FILLED IN ALL EXPIRY DATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321617 DEPUY ASR XL FEM IMP SIZE 47 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD. 8010379 1199934

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention