BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL

    MDR report key: 2963734 · Received February 15, 2013

    Report

    Report Number
    0002249697-2013-00687
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 27, 2013
    Report Date
    January 27, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K013676
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. NO MEDICAL RECORDS OR XRAYS WERE PROVIDED FOR REVIEW. THE DEVICE WAS NOT RETURNED FOR EVALUATION. WHILE THE REPORTED EVENT WAS NOT CONFIRMED, IT IS PROBABLE FROM THE EVENT DESCRIPTION THAT THE ROOT CAUSE OF THE PULLING OF THE TRIDENT SHELL FROM THE PELVIS WAS CAUSED AS A RESULT OF PATIENT TRAUMA. IT IS REPORTED THAT THE HOSPITAL NOTED THAT THERE WAS NOTHING WRONG WITH THE IMPLANTS, JUST THAT THE PATIENT FELL. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT RECEIVED A HIP REPLACEMENT ON (B)(6) 2013 AND WHILE IN THE HOSPITAL, FELL IN THE BATHROOM AND PULLED THE ACETABULAR CUP FROM THE PELVIS. THE DOCTOR PREFORMED A REVISION SURGERY AND REPLACEMENT WITH STRYKER IMPLANTS.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED A HIP REPLACEMENT ON (B)(6)-2013 AND WHILE IN THE HOSPITAL, FELL IN THE BATHROOM AND PULLED THE ACETABULAR CUP FROM THE PELVIS. THE DOCTOR PREFORMED A REVISION SURGERY AND REPLACEMENT WITH STRYKER IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68025 TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 42436301

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| O| R