BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*STM STD,42 NK,20X15X165

    MDR report key: 4181379 · Received October 17, 2014

    Report

    Report Number
    1818910-2014-30180
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    January 12, 2012
    Report Date
    March 28, 2013
    Manufacturer
    DEPUY IRELAND ¿ REG. # 9616671
    Product Code
    JDI
    PMA / PMN Number
    PK951422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. 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

    PPD AND MEDICAL RECORDS RECEIVED. THIS COMPLAINT ISLEGAL. PPD ALLEGES INFECTION. PATIENT WAS REVISED ON (B)(6) 2012 FOR INFECTIONAND ALL IMPLANTS WERE REMOVED AND SPACERS WERE PLACED. THE STEM/SLEEVEAND FEMORAL HEAD ARE DEPUY PRODUCTS AND ALL OTHER PRODUCTS ARE COMPETITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660219 S-ROM*STM STD,42 NK,20X15X165 HIP FEM STEM JDI DEPUY IRELAND ¿ REG. # 9616671 2319671

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention