BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 52

    MDR report key: 4820296 · Received June 4, 2015

    Report

    Report Number
    1818910-2015-22771
    Event Type
    Injury
    Date Received
    June 4, 2015
    Report Date
    May 22, 2015
    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
    NY, US
    Reporter Occupation
    ATTORNEY

    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. 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. UDI: UNAVAILABLE. THIS COMPLAINT IS THE SUBJECT OF LITIGATION OR A LEGAL CLAIM AND CURRENTLY COMPLETE PRODUCT DETAIL IS NOT AVAILABLE AT THIS TIME. A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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

    LITIGATION PAPERS ALLEGE PAIN, STIFFNESS, DISCOMFORT, WEAKNESS AND EXCESSIVE METAL ION LEVELS.

    Description of Event or Problem · 1

    UPDATE REC'D 12/11/2015- PPD RECEIVED. DOB WAS PROVIDED. THE PART/LOT INFORMATION FOR THE PRODUCTS WAS PROVIDED FROM THE PATIENT STICKER SHEET. THE COMPLAINT WAS UPDATED ON 12/22/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361369 ASR ACETABULAR CUPS 52 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD - 8010379 2775705

    Patients

    Seq Age Sex Outcome Treatment
    1 Other