BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 DEG INSERT 36MM

    MDR report key: 3781451 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01559
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    December 19, 2012
    Report Date
    April 7, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K062419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICES WERE ADDED IN THIS REPORT: SIZE 6 ACCOLADE II 127 DEG; CAT# 6721-0635; LOT# 36824406. PRIMARY TITANIUM HEMI SOLIDBACK CUP 50MM; CAT# 500-03-50D; LOT# MLMPJK. DELTA V-40 CERAMIC HEAD 36/-5; CAT# 6570-0-036; LOT# 41844804. 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 (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. (B)(4).

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN INVOLVING A TRIDENT LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION AND RESULTS. THE DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS RECEIVED AND EVALUATION INDICATED THAT. A MEDICAL REVIEW WAS COMPLETED AND CONCLUDED THERE IS NO DOCUMENTATION TO CONFIRM THE COMPLAINTS NOTED IN THE EVENT DESCRIPTIONS. THERE IS NO FOLLOW-UP DOCUMENTED AFTER (B)(6) 2013. DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT DOCUMENTATION WAS PROVIDED. FURTHER INFORMATION SUCH AS PATHOLOGY REPORT IS NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS MINOR PAIN IN LEFT HIP. HE ALSO THINKS HIS METAL LEVELS MIGHT BE GOING UP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS MINOR PAIN IN LEFT HIP. HE ALSO THINKS HIS METAL LEVELS MIGHT BE GOING UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260595 TRIDENT 0 DEG INSERT 36MM IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MLP9VR

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other