BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT X3 ELEVATED RIM 36MM ID

    MDR report key: 3875340 · Received June 16, 2014

    Report

    Report Number
    0002249697-2014-02319
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    August 9, 2011
    Report Date
    May 28, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: TRIDENT PSL HA CLUSTER 52MM; CAT# 542-11-52E; LOT# MKK26Y. V40 COCR LFIT HEAD 36MM/0; CAT# 6260-9-136; LOT# MJTJMY. 6.5 CANCELLOUS BONE SCREW 30MM; CAT# 2030-6530-1; LOT# MKKYP9. 6.5 CANCELLOUS BONE SCREW 25MM; CAT# 2030-6525-1; LOT# MKL974. ACCOLADE TMZF HIP STEM #0; CAT# 6020-0030; LOT# 36419003. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S PAIN. AN EVENT REGARDING PAIN INVOLVING A TRIDENT LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: A MEDICAL REVIEW WAS PERFORMED AND CONCLUDED: "THERE IS NO DOCUMENTED DESCRIPTION ON FOLLOW-UP THROUGH FEBRUARY 27, 2013 OF THE COMPLAINTS NOTED IN THE EVENT DESCRIPTION. THE STATEMENT ¿CANNOT LIE ON HER LEFT SIDE¿ SUGGESTS TROCHANTERIC BURSITIS. THERE IS NO EVIDENCE THAT FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS ARE RESPONSIBLE FOR THIS CLINICAL SITUATION." DEVICE HISTORY REVIEW: REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE PAIN COULD NOT BE DETERMINED. A MEDICAL REVIEW WAS PERFORMED AND DETERMINED THAT THERE WAS NO EVIDENCE OF A DEVICE RELATED ISSUE BASED ON THE INFORMATION AVAILABLE. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED PAIN IS A KNOWN POSSIBLE ADVERSE OUTCOME OF SURGERY.

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN LEFT 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 (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. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    PATIENT REPORTS PAIN SINCE SURGERY AND HAS TROUBLE WALKING. PATIENT CAN NOT LAY ON HER LEFT HIP.

    Description of Event or Problem · 1

    PATIENT REPORTS PAIN SINCE SURGERY AND HAS TROUBLE WALKING. PATIENT CANNOT LAY ON HER LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352520 TRIDENT X3 ELEVATED RIM 36MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MKKPLN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other