BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORATION ADM X3 INS 28/48

    MDR report key: 4635248 · Received March 26, 2015

    Report

    Report Number
    0002249697-2015-00929
    Event Type
    Injury
    Date Received
    March 26, 2015
    Date of Event
    December 10, 2014
    Report Date
    March 2, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K093644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES LISTED IN THIS REPORT: CAT 509-02-54E TRITANIUM REVISION ACETABULAR LOT CODE MMNJVW; CAT 626-00-42E MODULAR DUAL MOBILITY INSERT LOT CODE 44533301; CAT 18-2825 DELTA C-TAPER HEAD 28MM +2.5 LOT CODE 40723501; CAT 17-0000E TI SLEEVE FOR ALUMINA HEAD LOT CODE MJPT6N; CAT 5096-5415 RESTORATION ACETABULAR 54MM OD X 15MM WEDGE AUGMENT LOT CODE MLL8PJ; CAT 2080-0025 GAP PLATE SCREWS LOT CODE MMKJM9. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DISPOSITION UNKNOWN.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER SHOULD READ, "(B)(6)". DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS REPORTED FOR THE REPORTED MANUFACTURING LOT THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INFECTION IS MOST LIKELY A RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE IN THE HEALTHCARE FACILITY SETTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT I&D FOLLOWING REVISION SURGERY FOR INFECTION. MODULAR HEAD, MDM LINERS AND ADAPTER SLEEVE WHICH WERE PLACED ON (B)(6) 2013 WERE REPLACED. FEMORAL STEM AND ACETABULAR COMPONENT REMAINED WELL FIXED AND RETAINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT I&D FOLLOWING REVISION SURGERY FOR INFECTION. MODULAR HEAD, MDM LINERS AND ADAPTER SLEEVE WHICH WERE PLACED ON (B)(6) 2013 WERE REPLACED. FEMORAL STEM AND ACETABULAR COMPONENT REMAINED WELL FIXED AND RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202385 RESTORATION ADM X3 INS 28/48 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 44585101

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention