BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*STM STD,36NK,16X11X150

    MDR report key: 4915879 · Received July 15, 2015

    Report

    Report Number
    1818910-2015-25774
    Event Type
    Injury
    Date Received
    July 15, 2015
    Date of Event
    May 30, 2014
    Report Date
    June 16, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    PK851422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDED: THIS IS A DUPLICATE REPORT OF 1818910-2015-18856. THIS REPORT, 1818910-2015-25774 , WILL BE KEPT FOR INVESTIGATIONAL PURPOSES.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES THAT PATIENT SUFFERED FROM INFECTION, METALLOSIS, AND OSTEOLYSIS. UPDATE REC¿D 12/03/2014 - PATIENT'S MEDICAL RECORDS WERE RECEIVED. RECORDS WERE REVIEWED FOR MDR REPORTABILITY. ACCORDING TO THE RECORDS THE PATIENT WAS REIMPLANTED ON (B)(6) 2014. DURING REIMPLANTATION, IT WAS NOTED THERE WAS A CRACK IN THE GREATER TROCHANTER. THE CRACK WAS TREATED WITH CABELING. THE PROSTALAC STEM IS BEING REPORTED AT THIS TIME. UPDATE REC'D 4/2/15 - LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND TOXIC COBALT CHROMIUM METAL IONS. UPDATE 6/16/15-PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED ONGOING/CHRONIC INFECTION (COM 051576), PAIN, SYNOVITIS, AND PRE-EXISTING OSTEOLYSIS AND METALLOSIS (COM 051576). A PREVIOUS OPERATIVE NOTE FROM (B)(6) 2014 INDICATED NORMAL METAL ION LEVELS. PROSTALAC WAS PLACED DURING THE (B)(6) 2014 REVISION AND THE PATIENT WAS REIMPLANTED ON 9/10/2014. AFTER REMOVING THE PROSTALAC STEM ON (B)(6) 2014 A NON-DISPLACED FRACTURE WAS NOTICED. THE FRACTURE WAS CABELED. THE CUP, STEM/SLEEVE, AND HOLE ELIMINATOR ARE BEING REPORTED FOR THE ALLEGED INFECTION SINCE IT HAS BEEN CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460038 S-ROM*STM STD,36NK,16X11X150 HIP FEMORAL STEM/SLEEVE JDI DEPUY ORTHOPAEDICS INC US 1935528

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention