BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DEPUY ASR SLEEVE

    MDR report key: 3790948 · Received May 5, 2014

    Report

    Report Number
    1818910-2014-18123
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    January 27, 2014
    Report Date
    May 8, 2014
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT WAS REPORTED IN ERROR AS THIS IS A PINNACLE COMPLAINT AND NO SLEEVE WAS IMPLANTED IN THE PATIENT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS MOM SENSITIVITY, PSEUDOTUMOR, AND INSTABILITY. UPDATE: (B)(4) 2014 - MEDICAL RECORDS RECEIVED. PATIENT WAS REVISED TO ADDRESS PAIN AND DISLOCATION UPON REVISION, BROWN CLOUDY FLUID AND CORROSION WERE NOTED. THE ADAPTER SLEEVE AND FEMORAL STEM ARE NOW BEING ADDED TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON: (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266583 UNKNOWN DEPUY ASR SLEEVE HIP FEMORAL STEM/SLEEVE KWA DEPUY INTL., LTD. - 8010379 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR