BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT ALUMINA INSERT

    MDR report key: 3940648 · Received July 17, 2014

    Report

    Report Number
    0002249697-2014-02751
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MRA
    PMA / PMN Number
    P000013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INSTABILITY INVOLVING A TRIDENT ALUMINA INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS WAS PROVIDED HOWEVER WERE REJECTED FOR EVALUATION BY A CLINICIAN DUE TO INSUFFICIENT INFORMATION. DEVICE HISTORY REVIEW. INDICATED THAT THE SPECIFIED LOT WAS ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THAT THERE HAVE NOT BEEN ANY OTHER EVENTS FOR THE SPECIFIED LOT. THE REPORTED EVENT INVOLVES THE PATIENT SUSTAINING A FALL AND A SUBSEQUENT FEELING OF INSTABILITY. THE PATIENT WAS REVISED TO A MDM LINER WHICH PROVIDED STABILITY. THE FEMORAL AND ACETABULAR COMPONENTS WERE WELL FIXED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE NOT ENOUGH INFORMATION WAS PROVIDED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME

    Description of Event or Problem · 1

    PATIENT HAD HIS HIP REPLACED IN BLOOMINGTON, IL. THE PATIENT HAD FALLEN IN 2012, SINCE HIS FALL HE HAD FELT UNSTABLE. HIS SURGEON REFERRED THE PATIENT TO ANOTHER SURGEON FOR REVISION SURGERY AT THAT TIME. IT WAS NOTED IN THE CASE THAT PATIENTS' HIP WAS UNSTABLE. THE SURGEON CHECKED IMPLANTS TO SEE IF THEY WERE STABLE. BOTH THE FEMORAL AND ACETABULAR COMPONENTS WERE WELL FIXED. HE THEN PUT A MDM LINER IN AND WAS ABLE TO ACHIEVE STABILITY.

    Description of Event or Problem · 1

    PATIENT HAD HIS HIP REPLACED IN (B)(6). THE PATIENT HAD FALLEN IN 2012, SINCE HIS FALL HE HAD FELT UNSTABLE. HIS SURGEON REFERRED THE PATIENT TO ANOTHER SURGEON FOR REVISION SURGERY AT THAT TIME. IT WAS NOTED IN THE CASE THAT PATIENTS' HIP WAS UNSTABLE. THE SURGEON CHECKED IMPLANTS TO SEE IF THEY WERE STABLE. BOTH THE FEMORAL AND ACETABULAR COMPONENTS WERE WELL FIXED. HE THEN PUT A MDM LINER IN AND WAS ABLE TO ACHIEVE STABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419190 TRIDENT ALUMINA INSERT IMPLANT MRA STRYKER ORTHOPAEDICS-MAHWAH 19563202

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R