BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT ALUMINA INSERT

    MDR report key: 6087207 · Received November 8, 2016

    Report

    Report Number
    0002249697-2016-03495
    Event Type
    Injury
    Date Received
    November 8, 2016
    Date of Event
    October 1, 2016
    Report Date
    January 9, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MRA
    PMA / PMN Number
    P000013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING ALTR (PSEUDOTUMOR) INVOLVING AN EXETER STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION AND RESULTS: NOT PERFORMED, DEVICE WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT CONCLUDED THAT THE "ROOT CAUSE OF FAILURE UNCERTAIN DUE TO LACK OF INFORMATION AND THIS CASE REQUIRES MORE INFORMATION TO SOLVE ADEQUATELY." DEVICE HISTORY REVIEW: ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAS BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS RETURN OF THE DEVICE, SERIAL X-RAYS, OPERATIVE REPORTS, HISTOPATHOLOGY REPORTS, AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT A FEMALE PATIENT WHO HAD BEEN IMPLANTED WITH AN ALUMINA HEAD, ALUMINA LINER, TRIDENT SHELL AND EXETER STEM HAD DEVELOPED PSEUDOTUMOURS REQUIRING REVISION SURGERY.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT A FEMALE PATIENT WHO HAD BEEN IMPLANTED WITH AN ALUMINA HEAD, ALUMINA LINER, TRIDENT SHELL AND EXETER STEM HAD DEVELOPED PSEUDOTUMOURS REQUIRING REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738216 TRIDENT ALUMINA INSERT PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE MRA STRYKER ORTHOPAEDICS-MAHWAH 20876301

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R