BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT ALUMINA INSERT

    MDR report key: 4221667 · Received November 3, 2014

    Report

    Report Number
    0002249697-2014-04118
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MRA
    PMA / PMN Number
    P000013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. HOSPITAL POLICY.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) INCHES IN HEIGHT. AN EVENT REGARDING SEATING/LOCKING ISSUES INVOLVING A TRIDENT LINER WAS REPORTED. THE EVENT WAS CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: A MEDICAL REVIEW WAS PERFORMED AND CONCLUDED: "TWO RELEVANT PROCEDURE-RELATED FACTORS PRESENT IN THIS CASE ARE OVERHANGING OSTEOPHYTES THAT WERE NOT REMOVED AT IMPLANTATION SURGERY WHILE IT IS ALSO POSSIBLE THAT THE SCREWS AS USED FOR AUGMENTATION OF CUP FIXATION HAVE INTERFERED WITH PROPER LINER SEATING THROUGH A PROTRUDING SCREW HEAD. THIS PI CASE IS NOT DEVICE-RELATED." CONCLUSIONS: A MEDICAL REVIEW WAS PERFORMED AND INDICATED THAT THERE WAS NO EVIDENCE OF A DEVICE RELATED ISSUE. THE EXACT ROOT CAUSE OF THE EVENT HOWEVER COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION, INCLUDING OPERATIVE REPORTS, PROGRESS NOTES, AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT.

    Description of Event or Problem · 1

    TRIDENT PSL CUP WITH CERAMIC LINER REVISED. THE LINER DOES NOT APPEAR FULLY SEATED. THIS CONSTRUCT WAS ARTICULATING WITH A DEPUY SROM STEM WITH A BIOLOX HEAD. PATIENT EXPERIENCING RIGHT HIP PAIN.

    Description of Event or Problem · 1

    TRIDENT PSL CUP WITH CERAMIC LINER REVISED. THE LINER DOES NOT APPEAR FULLY SEATED. THIS CONSTRUCT WAS ARTICULATING WITH A DEPUY SROM STEM WITH A BIOLOX HEAD. PATIENT EXPERIENCING RIGHT HIP PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702918 TRIDENT ALUMINA INSERT IMPLANT MRA STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention