BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTER SLEEVES 12/14 +2

    MDR report key: 4260497 · Received November 19, 2014

    Report

    Report Number
    1818910-2014-31944
    Event Type
    Injury
    Date Received
    November 19, 2014
    Date of Event
    November 5, 2013
    Report Date
    October 22, 2014
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    ANONYMOUS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.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

    PATIENT WAS REVISED TO ADDRESS PAIN AND ELEVATED METAL ION LEVELS.REVISED WITH PINNACLE IMPLANTS.UPDATE REC'D 10/22/2014- LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES PAIN, DISCOMFORT, SORENESS, AND ELEVATED METAL ION LEVELS. THE STEM AND SLEEVE ARE BEING ADDED TO THE COMPLAINT. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 11/19/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749551 ADAPTER SLEEVES 12/14 +2 HIP FEMORAL STEM/SLEEVE KWA DEPUY INTL., LTD. - 8010379 2824298

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention