BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTER SLEEVE 11/13 +6

    MDR report key: 6075643 · Received November 3, 2016

    Report

    Report Number
    1818910-2016-30750
    Event Type
    Injury
    Date Received
    November 3, 2016
    Report Date
    October 21, 2016
    Manufacturer
    DEPUY INTL., LTD. 8010379
    Product Code
    KWL
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: UNAVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    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

    LITIGATION ALLEGES PATIENT SUFFERS FROM METALLOSIS AND PAIN. UPDATE 10/21/2016 MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE RIGHT HIP ((B)(4) - ALSO ASR) ALLEGES HIGH METAL ION LEVELS. THE STEM AND TAPER SLEEVE ARE BEING ADDED FOR THE LEFT HIP AS THEY CANNOT BE EXCLUDED AS THE CAUSE OF THE HIGH METAL ION LEVELS. THE COMPLAINT WAS UPDATED ON: 11/3/2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726415 ADAPTER SLEEVE 11/13 +6 HIP OTHER IMPLANT KWL DEPUY INTL., LTD. 8010379 2908184

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention