BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTER SLEEVES 12/14 +8

    MDR report key: 3895461 · Received June 25, 2014

    Report

    Report Number
    1818910-2014-21987
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    DEPUY INTL., 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
    MN, US
    Reporter Occupation
    ATTORNEY

    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. 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.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PARTIAL LOSS OF MOBILITY AND RANGE OF MOTION AND PAIN. (REVISION SCHEDULED FOR (B)(6) 2014). UPDATE REC¿D (B)(6) 2014 - DER, IMPLANT MEDICAL RECORDS AND X-RAYS RECEIVED. PATIENT REVISED TO ADDRESS PAIN AND ELEVATED METAL ION LEVELS. THE ADAPTER SLEEVE IS BEING ADDED TO THE COMPLAINT FOR PAIN. THIS COMPLAINT WAS UPDATED ON: (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369790 ADAPTER SLEEVES 12/14 +8 HIP FEMORAL STEM/SLEEVE KWA DEPUY INTL., LTD. - 8010379 1972608

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention