BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0° X3 INSERT 36MM ID

    MDR report key: 2944354 · Received February 5, 2013

    Report

    Report Number
    0002249697-2013-00571
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    April 21, 2010
    Report Date
    January 28, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER HIP DEVICES WERE ALSO LISTED IN THIS REPORT: SECUR-FIT MAX 132 HIP STEM #7, CAT# 6051-0730S, LOT# MJDJJ2. C-TAPER COCR LFIT HEAD 36MM/+5, CAT# 06-3605, LOT# MHPL9W. TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL, CAT# 502-11-52E, LOT# 33096501. 6.5 CANCELLOUS BONE SCREW 30MM, CAT# 2030-6530-1, LOT# MJENMV. 6.5 CANCELLOUS BONE SCREW 30MM, CAT# 2030-6530-1, LOT# MJEXDP. 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, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6). AN EVENT REGARDING PAIN INVOLVING A TRIDENT ACETABULAR LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED DUE TO THE MINIMAL INFORMATION SUPPLIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: PATIENT HAS HAD SOME PAIN IN HER HIP. PATIENT IS REPORTING THAT SINCE HAVING SURGERY, HER INCISION SITE HAS NOT HEALED. PATIENT WANTS TO KNOW IF IMPLANT IS THE CAUSE OF HER INCISION SITE NOT HEALING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: PATIENT HAS HAD SOME PAIN IN HER HIP. PATIENT IS REPORTING THAT SINCE HAVING SURGERY, HER INCISION SITE HAS NOT HEALED. PATIENT WANTS TO KNOW IF IMPLANT IS THE CAUSE OF HER INCISION SITE NOT HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48358 TRIDENT 0° X3 INSERT 36MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MJH1L8

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other