BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORATION ADM X3 INS

    MDR report key: 3700492 · Received March 26, 2014

    Report

    Report Number
    0002249697-2014-00897
    Event Type
    Injury
    Date Received
    March 26, 2014
    Date of Event
    February 27, 2014
    Report Date
    February 27, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K103233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES LISTED IN THIS REPORT: CAT # 626-00-38D, LOT # 38009604, DESCRIPTION: MODULAR DUAL MOBILITY INSERT. CAT # 6260-9-222, LOT # 37684901, DESCRIPTION: 22.2MM +3 LFIT V40 HEAD. 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 BECAUSE THE PATIENT WOULD NOT RELEASE THEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A RESTORATION ADM X3 INS WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. A MEDICAL REVIEW WAS NOT PERFORMED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. THE DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS BELIEVED THAT THE PATIENT HAD AN INFECTION. THE SURGEON REMOVED THE HEAD/LINER/INSERT, TOOK CULTURES, WASHED OUT THE HIP AND REPLACED WITH NEW COMPONENTS. THE PATIENT HAD PRESENTED TO THE PHYSICIAN WITH PAIN. PATIENT UNDERWENT A SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS BELIEVED THAT THE PATIENT HAD AN INFECTION THAT WAS CAUSED BY STAPHYLOCOCCUS. THE SURGEON REMOVED THE HEAD/LINER/INSERT, TOOK CULTURES, WASHED OUT THE HIP AND REPLACED WITH NEW COMPONENTS. THE PATIENT HAD PRESENTED TO THE PHYSICIAN WITH PAIN. PATIENT UNDERWENT A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177635 RESTORATION ADM X3 INS IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH 37721701

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R