BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DEPUY ASR SLEEVE

    MDR report key: 3725812 · Received April 3, 2014

    Report

    Report Number
    1818910-2014-15923
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    February 15, 2013
    Report Date
    March 21, 2014
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KXA
    Removal / Correction Number
    Z-1749/1816-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER WPC 493-2013. REASON FOR ORIGINAL COMPLAINT ¿ LITIGATION ALLEGES PATIENT HAD PAIN AFTER ASR HIP IMPLANT. UPDATE: (B)(6) 2013 - SALES REP REPORTED REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS PAIN. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: (B)(6) 2014. UPDATE: (B)(6) 2014 - PPD'S WITH MEDICAL RECORDS RECEIVED. DURING REVISION SURGERY, SCAR TISSUE AND CORROSION ON THE TAPER WERE NOTED. THE STEM AND SLEEVE HAVE BEEN ADDED TO THE COMPLAINT. STEM LEFT IN SITU. THIS COMPLAINT WAS UPDATED ON: (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201124 UNKNOWN DEPUY ASR SLEEVE HIP FEMORAL STEM/SLEEVE KXA DEPUY INTL., LTD. - 8010379 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR