BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 56

    MDR report key: 5476867 · Received March 3, 2016

    Report

    Report Number
    1818910-2016-14564
    Event Type
    Injury
    Date Received
    March 3, 2016
    Date of Event
    December 7, 2015
    Report Date
    February 24, 2016
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. (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

    PRODUCT COMPLAINT # ==> PC-000154626 INVESTIGATION SUMMARY ==> THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN. THE INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS WAS CONDUCTED UNDER MDD CAPA-(B)(4). ONGOING POST MARKET SURVEILLANCE IS CONDUCTED PER OUR PROCEDURES FOR THIS PRODUCT. DEVICE HISTORY LOT ==> NULL DEVICE HISTORY BATCH ==> NULL DEVICE HISTORY REVIEW ==> NULL IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A REVISION TO ADDRESS CUP LOOSENING AND PAIN.

    Description of Event or Problem · 1

    ASR REVISION ASR XL RIGHT HIP REASON(S) FOR REVISION: COMPONENT LOOSENING / PAIN UPDATE: SEE (B)(6) EMAIL DATED (B)(6) 2016. UPDATED REASONS FOR REVISION: COMPONENT LOOSENING (CUP). STEM LOT NUMBER UNAVAILABLE. (LF (B)(6) 2016). *** UPDATE - ALERT DATE (B)(6) 2016 *** COM MARKED AS LEGAL. KID 7784. ADDED KID IN SECONDARY REFERENCE FIELD, REQUESTED CONFIRMATION OF LITIGATION - SEE ATTACHMENT DATED (B)(6) 2016. EK (B)(6) 2017. ****************** DOI: (B)(6) 2005; DOR:(B)(6) 2015; RIGHT HIP

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132472 TOTAL ASR ACET IMP SIZE 56 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD - 8010379 1825218

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention