BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 10° X3 INSERT 36MM ID

    MDR report key: 3186971 · Received June 25, 2013

    Report

    Report Number
    0002249697-2013-02034
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    September 16, 2008
    Report Date
    June 5, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS A LEFT UNKNOWN STRYKER HIP.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 PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING PAIN RELATED TO A TRIDENT ACETABULAR LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. REVIEW OF THE PROVIDED RECORDS BY A CONSULTING CLINICIAN INDICATED: "IN REVIEWING THE MANY HANDWRITTEN NOTES IN THIS CASE, THE PATIENT¿S PAIN APPEARS RELATED TO LUMBAR RADICULITIS, CHRONIC PAIN SYNDROME, AND NEUROPATHY RATHER THAN FACTORS ASSOCIATED WITH PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS." DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. COMPLAINT HISTORY REVIEW WAS NOT PERFORMED AS NO DEVICE SPECIFIC FAILURE MODES WERE IDENTIFIED. PAIN CAN OCCUR POST-OPERATIVELY FOR A NUMBER OF REASONS AND IS A SYMPTOM RATHER THAN THE CAUSE OF THE ISSUE THE PATIENT IS EXPERIENCING. CLINICIAN REVIEW OF THE PROVIDED RECORDS INDICATED THE LIKELY ROOT CAUSE OF THE REPORTED PAIN TO BE RELATED TO PATIENT FACTORS. THE FOLLOWING OTHER DEVICES WERE ADDED IN THIS REPORT: TRIDENT PSL HA SOLID BACK 52MM; CAT# 540-11-52E; LOT# 0M5MMA SECUR-FIT HA 132 HIP STEM #9; CAT# 6051-0935A; LOT# M5RMLA C-TAPER COCR LFIT HEAD 36MM/+5; CAT# 06-3605; LOT# 14501501 IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS BILATERAL HIP IMPLANTS. PATIENT STATES THAT HER LEFT HIP IS NOT AS PAINFUL AS HER RIGHT HIP. PATIENT DOES STATE THAT THERE IS SOME PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS BILATERAL HIP IMPLANTS. PATIENT STATES THAT HER LEFT HIP IS NOT AS PAINFUL AS HER RIGHT HIP. PATIENT DOES STATE THAT THERE IS SOME PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288945 TRIDENT 10° X3 INSERT 36MM ID IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH JD6MLA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other