BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTER SLEEVE 11/13 +0

    MDR report key: 3180715 · Received June 20, 2013

    Report

    Report Number
    1818910-2013-19418
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 6, 2014
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK004627
    Removal / Correction Number
    Z-1749/1816-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. 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.

    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. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO PAIN. UPDATE: (B)(6) 2013 - REVISION OPERATIVE REPORT RECEIVED STATING THERE WAS CLOUDY, BROWN JOINT FLUID AN D FRETTING BETWEEN THE HEAD BALL AND STEM. FEMORAL STEM, FEMORAL STEM SLEEVE, AND ASR SLEEVE HAVE BEEN ADDED TO THE COMPLAINT.

    Description of Event or Problem · 1

    UPDATE: (B)(4) 2014 - LITIGATION RECEIVED. LITIGATION ALLEGES PHYSICAL INJURIES, ELEVATED METAL ION LEVELS AND DISFIGUREMENT. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. COMMENT: THERE IS A SIDE DISCREPANCY. THE DER AND MEDICAL RECORDS STATE THE LEFT SIDE, WHILE LITIGATION STATES THE RIGHT FOR THIS REVISION DATE. THE PATIENT IS BILATERAL. FOR ACCURACY, THE SIDE AND DOR FROM THE DER WILL REMAIN. SHOULD WE RECEIVE ADDITIONAL INFORMATION, WE WILL UPDATE IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280847 ADAPTER SLEEVE 11/13 +0 SLEEVE KWA DEPUY INTL., LTD. - 8010379 2071793

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR