BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TRIDENT ACETABULAR COMPONENT

    MDR report key: 6063799 · Received October 28, 2016

    Report

    Report Number
    0002249697-2016-03387
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    September 24, 2016
    Report Date
    October 2, 2016
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. REMAIN IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DR. (B)(6), SURGEON AT THE CLINIC, REPORTED THE FOLLOWING EVENT TO (B)(6), (B)(6) STUDY MANAGER ORTHO: "PATIENT MR. (B)(6) IS LESS PAINFUL THAN LAST (B)(6) BUT HE STILL LIMPS FOR THE FIRST STEPS. FOR HIM WHO HAS (B)(6) YEARS, THE SITUATION IS BEARABLE IN THE SHORT TERM. IN THE MEDIUM AND LONG TERM, HE WOULD LIKE TO FIND HIS AUTONOMY BACK WHICH THE IMPLANTATION OF THE PROSTHESIS PERMITTED. AS FOR THE X-RAYS, THEY SHOW TWO THINGS: APPARENTLY IMPLANTS ARE ALWAYS FIXED BUT WITH GRANULOMAS, AT PERI-ACETABULAR AND FEMORAL WHICH ARE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715945 UNKNOWN TRIDENT ACETABULAR COMPONENT HIP IMPLANT KWA STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other