BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 50

    MDR report key: 3822522 · Received May 21, 2014

    Report

    Report Number
    1818910-2014-19185
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    June 22, 2012
    Report Date
    May 7, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    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

    ADDITIONAL NARRATIVE: 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 SIDE. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. CUP IMPLANT DATE: (B)(6) 2004. XL PRODUCTS IMPLANT DATE: (B)(6) 2005. ALL PRODUCTS REVISED: (B)(6) 2012. RESURFACING TO XL PATIENT - THIS IS THE 2ND OF 2 REVISIONS WHERE THE CUP WAS REVISED, PLEASE SEE (B)(4) FOR THE 1ST OF 2 REVISIONS. BI-LATERAL RESURFACING TO XL PATIENT - PLEASE SEE (B)(4) FOR 1ST LEFT REVISION AND (B)(4) FOR 2ND LEFT REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303734 TOTAL ASR ACET IMP SIZE 50 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 1195500

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention