BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*HEAD FEMORAL COCR 28+6

    MDR report key: 7618543 · Received June 20, 2018

    Report

    Report Number
    1818910-2018-62626
    Event Type
    Injury
    Date Received
    June 20, 2018
    Date of Event
    January 21, 2015
    Report Date
    May 21, 2018
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    JDI
    UDI-DI
    10603295170808
    PMA / PMN Number
    K920317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH , A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    PFF AND STICKER SHEETS RECEIVED. PFF ALLEGES ELEVATED METAL ION. THERE WERE NO LABORATORY RESULT TO SUPPORT ELEVATED METAL IONS. DURING THE REVISION, THE IMPLANTS THAT WAS REMOVED WAS NOT SPECIFIED. DOI: (B)(6) 2010 FOR HEAD AND LINER, DOI: (B)(6) 2009 FOR STEM, DOR: (B)(6) 2015 (LEFT HIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465002 S-ROM*HEAD FEMORAL COCR 28+6 S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS JDI DEPUY INTERNATIONAL LTD - 8010379 2787559 10603295170808

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention