BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAR IMPLANT, RIGHT, TRIDENT SIZE F ID

    MDR report key: 6702943 · Received July 11, 2017

    Report

    Report Number
    0002249697-2017-02164
    Event Type
    Injury
    Date Received
    July 11, 2017
    Date of Event
    June 7, 2017
    Report Date
    September 28, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., BUT SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S. REVIEW OF THE DEVICE HISTORY RECORDS THE INDICATE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. 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 UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PERIPROSTHETIC FRACTURE INVOLVING A PAR SPECIALTY IMPLANT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS NO ITEMS WERE RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: THE PROVIDED X-RAY WAS SUBMITTED TO A CONSULTING CLINICIAN WHO COMMENTED, "NO RECORDS WERE PROVIDED OTHER THAN AN AP XRAY OF THE PELVIS/RIGHT HIP. THE ENTIRE ACETABULAR REGION IS MISSING (RESECTED?). SITTING ABOVE THIS IS A ¿TUMOR PROSTHESIS¿ IN THE RIGHT ILIUM. THIS SADDLE TYPE PROSTHESIS IS MEANT TO BE ATTACHED TO THE INNER AND OUTER WALLS OF THE ILIAC WING. THERE ARE MASSIVE LUCENCIES IN THE BONE SURROUNDING THIS PROSTHESIS. THE ACETABULAR PORTION OF THE PROSTHESIS HAS DISSOCIATED WITH THE FEMORAL HEAD AND LINER ESCAPED FROM THE LOCKING RING.¿ DEVICE HISTORY REVIEW: DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT INFORMATION WAS PROVIDED. THE PROVIDED X-RAY WAS SUBMITTED TO A CONSULTING CLINICIAN WHO COMMENTED, "NO RECORDS WERE PROVIDED OTHER THAN AN AP XRAY OF THE PELVIS/RIGHT HIP. THE ENTIRE ACETABULAR REGION IS MISSING (RESECTED?). SITTING ABOVE THIS IS A ¿TUMOR PROSTHESIS¿ IN THE RIGHT ILIUM. THIS SADDLE TYPE PROSTHESIS IS MEANT TO BE ATTACHED TO THE INNER AND OUTER WALLS OF THE ILIAC WING. THERE ARE MASSIVE LUCENCIES IN THE BONE SURROUNDING THIS PROSTHESIS. THE ACETABULAR PORTION OF THE PROSTHESIS HAS DISSOCIATED WITH THE FEMORAL HEAD AND LINER ESCAPED FROM THE LOCKING RING.¿ IF THE DEVICES AND/OR ADDITIONAL INFORMATION ARE RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND RE-EVALUATED.

    Description of Event or Problem · 1

    PATIENT'S REMAINING ILIUM FRACTURED CAUSING THE SADDLE TO BECOME DISPLACED. IT WAS REPORTED THAT THE DISPLACEMENT CAUSED INTRAPROSTHETIC DISLOCATION OF THE CONSTRAINED LINER.

    Description of Event or Problem · 1

    PATIENT'S REMAINING ILIUM FRACTURED CAUSING THE SADDLE TO BECOME DISPLACED. IT WAS REPORTED THAT THE DISPLACEMENT CAUSED INTRAPROSTATIC DISLOCATION OF THE CONSTRAINED LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482988 PAR IMPLANT, RIGHT, TRIDENT SIZE F ID HIP IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH TAGR901

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R