BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT 10° CROSSFIRE INSERT 36 MM ID

    MDR report key: 4140305 · Received October 3, 2014

    Report

    Report Number
    0002249697-2014-03746
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K021911
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN AND A MALPOSITIONED SCREW INVOLVING A TRIDENT LINER WAS REPORTED. CONCLUSION: THE EVENT INVOLVES A SCREW THAT IS POSITIONED OUTSIDE THE PELVIC BONE. A MEDICAL REVIEW INDICATES THE DISCOLORATION SHOULD BE CONSIDERED HARMLESS AND A SECONDARY FINDING TO LONG TERM IMPLANTATION DUE TO PROTEIN AND BLOOD ABSORPTION INTO THE POLY. THE EVENT IS CONSIDERED PROCEDURE RELATED. FURTHERMORE, THERE IS NO ALLEGED FAILURE OF THE REPORTED LINER. BASED ON THE PROVIDED INFORMATION, THE PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 1

    PT CAME INTO THEATRE WITH HIP PAIN. PT HAD ACCOALDE TMZF AND TRIDENT CUP IMPLANTED APPROX 8 YEARS AGO. WHEN SURGEON OPENED UP THE PT HE HAD VERY INFLAMED TISSUE. DR TOOK V40 HEAD OFF STEM & THERE WAS BLACK TAR LIKE SUBSTANCE ON THE TRUNNION. DR BELIEVES THIS IS TRUNNIONOSIS. ALSO THE POLY WAS YELLOW. DR REPLACED LINER AND HEAD WITH X3 LINER AND NEW LFIT V40 FEMORAL HEAD.

    Description of Event or Problem · 1

    PT CAME INTO THEATRE WITH HIP PAIN. PT HAD ACCOLADE TMZF AND TRIDENT CUP IMPLANTED APPROX 8 YEARS AGO. WHEN SURGEON OPENED UP THE PT HE HAD VERY INFLAMED TISSUE. DR TOOK V40 HEAD OFF STEM & THERE WAS BLACK TAR LIKE SUBSTANCE ON THE TRUNNIONOSIS. DR BELIEVES THIS IS TRUNNIONS. ALSO THE POLY WAS YELLOW. DR REPLACED LINER AND HEAD WITH X3 LINER AND NEW LFIT V40 FEMORAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618463 TRIDENT 10° CROSSFIRE INSERT 36 MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH 1ZHCLA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other