BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 54

    MDR report key: 3971796 · Received July 31, 2014

    Report

    Report Number
    1818910-2014-24718
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 10, 2014
    Report Date
    November 28, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD.-8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    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.(B)(4). DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.(B)(4)

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN 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 THIS INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.ADDITIONAL NARRATIVE: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

    ASR REVISION REPORTED VIA SALES REP.ASR XL.RIGHT.REASON(S) FOR REVISION : UNKNOWN.

    Description of Event or Problem · 1

    UPDATE REC'D 11/28/2014 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES PAIN, STIFFNESS, DISCOMFORT, WEAKNESS, AND ELEVATED METAL ION LEVELS. THE DOI WAS PROVIDED. THE STEM AND SLEEVE ARE BEING ADDED TO THE COMPLAINT. THE INVOICE WAS LOCATED FOR PART/LOT INFORMATION. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 12/22/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446637 ASR ACETABULAR CUPS 54 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD.-8010379 2721764

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention