BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASR TAP SLV ADAP 12/14 -1

    MDR report key: 3911320 · Received July 3, 2014

    Report

    Report Number
    1818910-2014-22596
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 6, 2012
    Report Date
    June 9, 2014
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK070359
    Removal / Correction Number
    Z-1749/1816-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 (B)(4). REASON FOR ORIGINAL COMPLAINT - LITIGATION ALLEGES PATIENT HAD PAIN AND WEAKNESS, EXCESSIVE METAL DEBRIS AND DAMAGE TO THE BONES AFTER ASR HIP IMPLANT. UPDATE: ((B)(6) 2012) - PATIENT FACT SHEET WAS RECEIVED. THE PART/LOT NUMBERS HAVE BEEN UPDATED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE: (B)(6) 2014 - SALES REP REPORTED REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS PAIN. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THIS COMPLAINT WAS UPDATED ON: (B)(6) 2014. UPDATE REC¿D (B)(6) 2014 - MEDICAL RECORDS RECEIVED. UPON REVISION, METALLOSIS, CORROSION UNDER THE TRUNNION, OSTEOLYSIS, GRAY-GREEN SYNOVIAL TISSUE, AND A LARGE GLUTEUS MEDIUS AVULSION TEARING WERE NOTED. THE STEM REMAINED IN SITU. THE STEM AND SLEEVE ARE BEING ADDED TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON: (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389692 ASR TAP SLV ADAP 12/14 -1 HIP FEMORAL STEM/SLEEVE KWA DEPUY INTL., LTD. - 8010379 2920233

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR