BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT PSL HA CLUSTER 50MM

    MDR report key: 4123341 · Received September 26, 2014

    Report

    Report Number
    0002249697-2014-03661
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    April 15, 2014
    Report Date
    September 3, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K983382
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING INSTABILITY AND PAIN INVOLVING A TRIDENT LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: INSUFFICIENT INFORMATION WAS RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. DEVICE HISTORY REVIEW: ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENT FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS RETURN OF DEVICE, OPERATIVE REPORTS, X-RAYS, PATIENT HISTORY & FOLLOW-UP NOTES ARE NEEDED TO INVESTIGATE THIS EVENT FURTHER.

    Description of Event or Problem · 1

    POSTOPERTIVE DIAGNOSIS: PATIENT UNDERWENT REVISION FOLLOWING PRIMARY THA FOR HIP PAIN AND INSTABILITY. ALL COMPONENTS REVISED, EXCEPT FEMORAL COMPONENT, WHICH WAS FOUND TO BE WELL-FIXED.

    Description of Event or Problem · 1

    POSTOPERTIVE DIAGNOSIS: PATIENT UNDERWENT REVISION FOLLOWING PRIMARY THA FOR HIP PAIN AND INSTABILITY. ALL COMPONENTS REVISED, EXCEPT FEMORAL COMPONENT, WHICH WAS FOUND TO BE WELL-FIXED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602514 TRIDENT PSL HA CLUSTER 50MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH MLT0DA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention