BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0° X3 INSERT 36MM ID

    MDR report key: 4863507 · Received June 23, 2015

    Report

    Report Number
    0002249697-2015-02045
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    May 29, 2015
    Report Date
    May 29, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE PROVIDED INFORMATION IT HAS BEEN DETERMINED THAT THIS EVENT IS ASSOCIATED WITH AN OFF-LABEL APPLICATION. AS PER QIN 4350, REV H, STRYKER PRODUCT SHOULD NOT BE USED WITH COMPETITORS¿ DEVICES BECAUSE DESIGN, MATERIAL, OR TOLERANCE DIFFERENCES MAY LEAD TO PREMATURE DEVICE AND/OR FUNCTION FAILURE. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    PATIENT'S LEFT HIP WAS REVISED DUE TO RECURRENT DISLOCATIONS - PATIENT'S PRIMARY SURGERY UTILIZED BIOMET COMPONENTS DONE ON AN UNKNOWN DATE/LOCATION. THE PRIMARY BIOMET HIP COMPONENTS WERE REVISED ON (B)(6) 2014 TO INCLUDE A TRIDENT SHELL AND STRYKER LINER, BIOMET STEM AND HEAD REMAINED. SURGEON REPLACED WITH A STRYKER CONSTRAINED LINER AND THE BALL/HEAD WITH A BIOMET PART TO MATCH IMPLANTED BIOMET STEM.

    Description of Event or Problem · 1

    PATIENT'S LEFT HIP WAS REVISED DUE TO RECURRENT DISLOCATIONS - PATIENT'S PRIMARY SURGERY UTILIZED BIOMET COMPONENTS DONE ON AN UNKNOWN DATE/LOCATION. THE PRIMARY BIOMET HIP COMPONENTS WERE REVISED ON (B)(6) 2014 TO INCLUDE A TRIDENT SHELL AND STRYKER LINER, BIOMET STEM AND HEAD REMAINED. SURGEON REPLACED WITH A STRYKER CONSTRAINED LINER AND THE BALL/HEAD WITH A BIOMET PART TO MATCH IMPLANTED BIOMET STEM

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405496 TRIDENT 0° X3 INSERT 36MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MNMKM4

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention