BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3202652 · Received July 2, 2013

    Report

    Report Number
    1818910-2013-20409
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    October 21, 2003
    Report Date
    September 12, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    K851422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    UPDATE: (B)(6) 2013- UPON MEDICAL RECORD REVIEW BY A MEDICAL PROFESSIONAL, IT WAS DISCOVERED THAT THE PATIENT SUFFERED FROM IMPINGEMENT. THE CUP, STEM, AND SLEEVE HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES ABDUCTOR MUSCLE REPAIR, METAL WEAR AND ELEVATED METAL IONS. UPDATED PATIENT HARMS AND PATIENT'S STATE. ADDED REVISION HOSPITAL, REVISION SURGEON, LAWYER IN THE ASSOCIATED CONTACT AND LAW FIRM IN THE FACILITY NAME. DOI: (B)(6) 2003, DOR: OCT 21, 2003, (RIGHT HIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302690 S-ROM*STM STD,36NK,16X11X150 S-ROM HIP SYSTEM : HIP FEMORAL STEM JDI DEPUY ORTHOPAEDICS INC US 1041554

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention