BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT 0 DEG INSERT 40MM

    MDR report key: 3781380 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01581
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    September 28, 2007
    Report Date
    April 7, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K062419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICES WERE ADDED IN THIS REPORT: TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL; CAT# 502-11-54E; LOT# 23216801. SECUR-FIT ARC/HA COLLAR STEM#8; CAT# S-2337-HF08; LOT# 9PAMJD. C-TAPER COCR LFIT HEAD 40MM/-2.5; CAT# 06-4097; LOT# 4P6MMA. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS BASED ON INFORMATION PROVIDED IT APPEARS THAT DEVISE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPARTMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME DUE TO THE ONGOING LITIGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ATTORNEY FOR THE PATIENT AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY THE PATIENT IS EXPERIENCING AUDIBLE NOISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260271 TRIDENT 0 DEG INSERT 40MM IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH 34VMND

    Patients

    Seq Age Sex Outcome Treatment
    1 Other