BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT PSL HA SOLID BACK 52MM

    MDR report key: 2990050 · Received March 5, 2013

    Report

    Report Number
    0002249697-2013-00903
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K983382
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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).

    Additional Manufacturer Narrative · 1

    THERE WERE NO REPORTED DISCREPANCIES AND THERE WERE NO OTHER EVENTS FOR THE REFERENCED LOT. THE DEVICE WAS NOT RETURNED SO INSPECTION WAS POSSIBLE. INSUFFICIENT MEDICAL INFORMATION WAS RECEIVED FOR REVIEW WITH A CLINICIAN CONSULTANT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS RECEIVED. FURTHER INFORMATION SUCH AS RETURN OF DEVICE, PRE- AND POST-OPERATIVE X-RAYS AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. THE REPORTED EVENT REGARDING PERIPROSTHETIC FRACTURE INVOLVING A TRIDENT SHELL NOT CONFIRMED.

    Description of Event or Problem · 1

    PATIENT REPORTS TO THE SURGEON'S OFFICE COMPLAINING OF PAIN. UPON REVIEW OF THE X-RAY, THE SURGEON REPORTS AN ACETABULAR FRACTURE WITH A MALPOSITIONED CUP. PATIENT WAS ADMITTED TO THE HOSPITAL WHERE THE SURGEON CAREFULLY REMOVED THE CUP AND REPLACED IT WITH A TRITANIUM REVISION CUP, FIVE SCREWS, A NEW LINER AND A HEAD TO RECREATE THE PROPER LEG LENGTH AND STABILITY.

    Description of Event or Problem · 1

    PATIENT REPORTS TO THE SURGEON'S OFFICE COMPLAINING OF PAIN. UPON REVIEW OF THE X-RAY, THE SURGEON REPORTS AN ACETABULAR FRACTURE WITH A MALPOSITIONED CUP. PATIENT WAS ADMITTED TO THE HOSPITAL WHERE THE SURGEON CAREFULLY REMOVED THE CUP AND REPLACED IT WITH A TRITANIUM REVISION CUP, FIVE SCREWS, A NEW LINER AND A HEAD TO RECREATE THE PROPER LEG LENGTH AND STABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94284 TRIDENT PSL HA SOLID BACK 52MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 41696501

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| O| R