BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT PSL HA CLUSTER 50MM

    MDR report key: 3061332 · Received April 16, 2013

    Report

    Report Number
    0002249697-2013-01336
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 27, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K983382
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING REVISION OF A TRIDENT SHELL DURING REVISION OF A REJUVENATE MODULAR STEM WAS REPORTED. THE INDICATION FOR REVISION WAS REPORTED TO BE "PAIN" AND NO FURTHER DETAILS WERE PROVIDED. THE RETURNED ACETABULAR SHELL IS UNREMARKABLE. THE LACK OF INFORMATION PROVIDED PREVENTS ANY MEANINGFUL INVESTIGATION INTO THE REPORTED PAIN, WHICH IS A SYMPTOM AND NOT IN ITSELF CONSIDERED AN INDICATION FOR REVISION SURGERY. THERE IS NO EVIDENCE TO SUGGEST THIS PATIENT'S SYMPTOMS ARE RELATED TO THE ACETABULAR SHELL AND NOT THE MODULAR NECK-STEM SYSTEM WHICH IS THE SUBJECT OF VOLUNTARY RECALL.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT COMPLAINED OF PAIN. DR REVISED CUP AND STEM.

    Description of Event or Problem · 1

    PATIENT COMPLAINED OF PAIN. DR. REVISED CUP AND STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162270 TRIDENT PSL HA CLUSTER 50MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH MJKNKM

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention