BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0° CROSSFIRE INSERT 28MM ID

    MDR report key: 8528039 · Received April 18, 2019

    Report

    Report Number
    0002249697-2019-01670
    Event Type
    Injury
    Date Received
    April 18, 2019
    Date of Event
    March 25, 2019
    Report Date
    April 18, 2019
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    UDI-DI
    07613327037463
    PMA / PMN Number
    K983502
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: C-TAPER COCR LFIT HEAD 28MM/0; CAT# 06-2800; LOT# 84506101; UNKNOWN_JOINT REPLACEMENT_PRODUCT; CAT# UNK_JR; LOT# UNKNOWN. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    AS REPORTED BY REP: "RIGHT TOTAL HIP REVISION ARTHROPLASTY, ANTERIOR BALL LINER VERSUS COMPLETE. PRE-OP DIAGNOSIS: RIGHT FAILED TOTAL HIP ARTHROPLASTY. INTRA-OP SURGEON COMMENTS: PATIENT REPORTS PAIN". A FEMORAL HEAD, LINER, AND SCREW WERE REVISED. REP PROVIDED A RE-REVISION X-RAY AND EXPLANT PICTURES, AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322057 TRIDENT 0° CROSSFIRE INSERT 28MM ID PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 07613327037463

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R