BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM STM STD 36+12L 13X18

    MDR report key: 3834198 · Received May 28, 2014

    Report

    Report Number
    1818910-2014-19560
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    May 27, 2011
    Report Date
    July 7, 2014
    Manufacturer
    DEPUY IRELAND
    Product Code
    LPH
    PMA / PMN Number
    PK934412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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.EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    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. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT (B)(4). REASON FOR ORIGINAL COMPLAINT ¿ LITIGATION PAPERS ALLEGE PATIENT SUFFERED THE FOLLOWING PERSONAL AND ECONOMIC INJURIES AS A RESULT OF THE IMPLANTATION WITH THE ASR HIP IMPLANT: OCCASIONAL HIP PAIN WHEN WALKING QUICKLY AND MOVING UP AND DOWN STAIRS. PATIENT HAS NOT YET SCHEDULED AN EXPLANTATION OF THE ASR HIP IMPLANT. UPDATE (B)(4) 2012 - PART/LOT INFORMATION WAS IDENTIFIED. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE REC¿D (B)(4) 2014 - MEDICAL RECORDS RECEIVED. UPON REVISION MUCOID TANISH COLORED SYNOVIAL TISSUE, METALLOSIS, METAL DEBRIS, CORROSION, SYNOVITIS, AND NO BONY INGROWTH AT THE ACETABULUM WERE NOTED. THE ADAPTER SLEEVE, STEM 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
    313356 SROM STM STD 36+12L 13X18 HIP FEMORAL STEM/SLEEVE LPH DEPUY IRELAND 2353284

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other