BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL

    MDR report key: 3912020 · Received July 3, 2014

    Report

    Report Number
    0002249697-2014-02550
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K013676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 ALLEGED TRIDENT SHELL LOOSENING WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS NO DEVICES WERE RETURNED FOR EVALUATION. DEVICE HISTORY REVIEW INDICATED THAT ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THIS DEVICE AND EVENT ARE DETERMINED TO BE WITHIN THE SCOPE OF CAPA (B)(4) FOR TRIDENT LOOSENING. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY PUT IN (B)(6) 2007 AND HAS COMPLAINED OF PAIN EVER SINCE THE INITIAL SURGERY, GROIN PAIN SPECIFICALLY. ONCE SURGEON BEGAN REVISING THE ACETABULAR COMPONENT, HE NOTICED THE ACETABULAR SHELL WAS GROSSLY LOOSE. THE DOCTOR OPTED TO REVISE CUP USING A PRIMARY TRITANIUM CLUSTER SHELL AND AN MDM LINER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY PUT IN (B)(6) 2007 AND HAS COMPLAINED OF PAIN EVER SINCE THE INITIAL SURGERY, GROIN PAIN SPECIFICALLY. ONCE SURGEON BEGAN REVISING THE ACETABULAR COMPONENT, HE NOTICED THE ACETABULAR SHELL WAS GROSSLY LOOSE. THE DOCTOR OPTED TO REVISE CUP USING A PRIMARY TITANIUM CLUSTER SHELL AND AN MDM LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390698 TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 22019601

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R