BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 10° X3 INSERT 36MM ID

    MDR report key: 4869648 · Received June 25, 2015

    Report

    Report Number
    0002249697-2015-02084
    Event Type
    Injury
    Date Received
    June 25, 2015
    Date of Event
    June 2, 2015
    Report Date
    June 2, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER DEVICES LISTED IN THIS REPORT: CAT. NO.: 6570-0-236; DELTA V-40 CERAMIC HEAD 36/+5; LOT CODE: UNKNOWN. CAT. NO.: UNKNOWN; UNKNOWN SCREWS; LOT CODE: UNKNOWN. AN EVENT REGARDING PAIN INVOLVING A TRIDENT LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION COULD NOT BE PERFORMED AS NO ITEMS WERE RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: INSUFFICIENT INFORMATION WAS RECEIVED FOR A CLINICAL REVIEW. DEVICE HISTORY REVIEW COULD NOT BE PERFORMED AS THE LOT ID IS UNKNOWN. COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS THE LOT ID IS UNKNOWN. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION, INCLUDING RETURN OF DEVICE, OPERATIVE REPORTS, X-RAYS, PATIENT HISTORY, PROGRESS NOTES IS NEEDED TO FULLY INVESTIGATE THE EVENT. IF FURTHER INFORMATION AND/OR DEVICE BECOME AVAILABLE, THIS INVESTIGATION WILL BE RE-OPENED. PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    PATIENT WAS HAVING GROIN PAIN IN HIS LEFT HIP, SURGEON REMOVED SCREWS FROM CUP AND EXCHANGED THE HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412695 TRIDENT 10° X3 INSERT 36MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention