BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 10° X3 INSERT 32MM ID

    MDR report key: 3910571 · Received July 2, 2014

    Report

    Report Number
    0002249697-2014-02510
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 25, 2008
    Report Date
    June 9, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN AND FLUID DRAINING INVOLVING A TRIDENT LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. A DEVICE HISTORY REVIEW THE REPORTED DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK. A COMPLAINT HISTORY REVIEW NOT PERFORMED AS NO DEVICE SPECIFIC FAILURE MODES WERE REPORTED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION AND NO MEDICAL INFORMATION WAS PROVIDED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICES WERE ALSO LISTED IN THIS REPORT:DELTA V-40 CERAMIC HEAD 32/+4; CAT# 6570-0-232; LOT# 16673001.TRIDENT HEMISPHERICAL CLUSTER 50MM; CAT# 502-01-50D; LOT# 25974001.CITATION TMZF HA STEM #2 RIGHT; CAT# 6265-5112; LOT# 18072802.IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S PAIN.AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A RIGHT HIP REPLACEMENT ON (B)(6) 2008 AND IS HAVING PAIN IN GROIN AREA. X-RAY SHOWED MASS OF FLUID IN HIP AREA. PATIENT REPORTED SHE WAS IN SO MUCH PAIN THE DOCTOR HAD TO DRAIN FLUID.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A RIGHT HIP REPLACEMENT ON (B)(6), 2008 AND IS HAVING PAIN IN GROIN AREA. X-RAY SHOWED MASS OF FLUID IN HIP AREA. PATIENT REPORTED SHE WAS IN SO MUCH PAIN THE DOCTOR HAD TO DRAIN FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388095 TRIDENT 10° X3 INSERT 32MM ID IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH 7WKMED

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention