BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT PSL HA CLUSTER 58MM

    MDR report key: 3984276 · Received August 6, 2014

    Report

    Report Number
    0002249697-2014-03030
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 18, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K983382
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) INCHES IN HEIGHT. AN EVENT REGARDING REVISION DUE TO A CYST INVOLVING A TRIDENT PSL HA CLUSTER 58MM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: INDICATED THAT THE SPECIFIED LOT WAS ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: INDICATED THAT THERE HAVE NOT BEEN ANY OTHER EVENTS FOR THE SPECIFIED LOT. CONCLUSIONS: THE REPORTED EVENT INVOLVES THE REMOVAL OF THE PATIENT¿S SHELL DUE TO A CYST BEHIND THE SHELL. THE ROOT CAUSE OF THIS EVENT IS THE CYSTIC LESION IN THE ACETABULUM. THIS FACTOR IS PATIENT RELATED AND NOT DEVICE RELATED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE SURGEON AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A CYST BEHIND HIS ACETABULAR SHELL. DOCTOR WAS ABLE TO REMOVE HIS ACETABULAR SHELL AND REAM TO REMOVE THE AFFECTED AREA. HE THEN REIMPLANTED A TRITANIUM SHELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A CYST BEHIND HIS ACETABULAR SHELL. DOCTOR WAS ABLE TO REMOVE HIS ACETABULAR SHELL AND REAM TO REMOVE THE AFFECTED AREA. HE THEN REIMPLANTED A TRITANIUM SHELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461291 TRIDENT PSL HA CLUSTER 58MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 25165104

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention