BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 46

    MDR report key: 3181107 · Received June 20, 2013

    Report

    Report Number
    1818910-2013-19454
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    November 27, 2012
    Report Date
    August 21, 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
    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. 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

    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

    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.

    Description of Event or Problem · 1

    ASR REVISION; ASR XL - LEFT; REASON(S) FOR REVISION: PAIN.

    Description of Event or Problem · 1

    ASR REVISION; ASR XL - LEFT; REASON(S) FOR REVISION: PAIN. UPDATE RECEIVED (B)(4) 2014. TAPER SLEEVE AND STEM ADDED. LOT NUMBER NOT AVAILABLE FOR STEM.

    Description of Event or Problem · 1

    UPDATE - ATTACHED LEGAL DOCUMENT, ADDED ADDITIONAL REASONS FOR REVISION: PAIN, HIGH METAL ION LEVELS, ALLERGIC REACTION, METALLOSIS, AND DIFFICULTY IN MOVEMENT. MARKED LEGAL, ADDED PATIENTS NAME AND GENDER, ADDED ALL EXPIRY DATES, ALL MANUFACTURING DATES. TAKEN FROM LEGAL LETTER DATED (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280057 TOTAL ASR ACET IMP SIZE 46 HIP ACETABULAR CUP KWA DEPUY INTL., LTD. - 8010379 1800612

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention