BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 DEG INSERT 40MM

    MDR report key: 4241445 · Received November 10, 2014

    Report

    Report Number
    0002249697-2014-04224
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K061434
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING LOOSENING INVOLVING AN ACCOLADE STEM WAS REPORTED. CONCLUSION NO ALLEGATION OF FAILURE WAS MADE AGAINST THE THE DEVICE. BASED ON THE INFORMATION PROVIDED THERE IS NO INDICATION THAT THE PRODUCT REPORTED IN THIS INVESTIGATION CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE DOCTOR WAS PERFORMING A BURSECTOMY, DUE TO THE PATIENT COMPLAINING OF HIP PAIN, AFTER EXCHANGING THE POLY THE DOCTOR PULLED ON THE STEM AND REALIZED IT WAS LOOSE. HE THEN EXTRACTED THE STEM AND REIMPLANTED AN ACCOLADE 2.

    Description of Event or Problem · 1

    THE DOCTOR WAS PERFORMING A BURSECTOMY, DUE TO THE PATIENT COMPLAINING OF HIP PAIN, AFTER EXCHANGING THE POLY THE DOCTOR PULLED ON THE STEM AND REALIZED IT WAS LOOSE. HE THEN EXTRACTED THE STEM AND REIMPLANTED AN ACCOLADE 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722241 TRIDENT 0 DEG INSERT 40MM IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MHLTPL

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention