BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 10° X3 INSERT 32MM ID

    MDR report key: 2926067 · Received January 23, 2013

    Report

    Report Number
    0002249697-2013-00181
    Event Type
    Injury
    Date Received
    January 23, 2013
    Date of Event
    February 1, 2007
    Report Date
    January 9, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS A TRIDENT RIGHT HIP. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. THE PROVIDED MEDICAL INFORMATION WAS REVIEWED BY A CONSULTING CLINICIAN WHO CONCLUDED: ¿THERE IS NO EVIDENCE THAT FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS WERE RESPONSIBLE FOR THE COMPLAINTS NOTED IN THE EVENT DESCRIPTION.¿ THE EVENT COULD NOT BE CONFIRMED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE THERE IS NO DOCUMENTATION OF THE COMPLAINTS ALLUDED TO IN THE EVENT DESCRIPTION IN THE PROVIDED MEDICAL RECORDS AND NO RADIOGRAPHIC EVIDENCE OF PATHOLOGY RELATED TO THE RIGHT TOTAL HIP. FURTHER INFORMATION SUCH AS FOLLOW-UP NOTES SUBSEQUENT TO (B)(6) 2010 ARE NEEDED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    THE PATIENT REPORTS DISCOMFORT IN THE RIGHT HIP THAT BEGAN IN (B)(6) 2007. THE HIP OFTEN MOVES SLIGHTLY OUT OF PLACE AND CATCHES AND LOCKS WHEN RISING FROM A SEATED POSITION, SHIFTING WHILE SEATED AND LIFTING HER LEG TO GET INTO BED. THE PATIENT STATES SHE HAS TO WIGGLE TO MOVE THE HIP BACK INTO PLACE. SHE HAS GONE TO THE HOSPITAL EMERGENCY ROOM TWICE FOR EXTREME PAIN CAUSED BY JOINT MOVEMENT AND SEVERE MUSCLE JERKING IN THE HIP. THE PATIENT IS UNSATISFIED WITH THE SURGEON'S EXPLANATION OF THE CAUSE.

    Description of Event or Problem · 1

    THE PATIENT REPORTS DISCOMFORT IN THE RIGHT HIP THAT BEGAN IN (B)(6) 2007. THE HIP OFTEN MOVES SLIGHTLY OUT OF PLACE AND CATCHES AND LOCKS WHEN RISING FROM A SEATED POSITION, SHIFTING WHILE SEATED AND LIFTING HER LEG TO GET INTO BED. THE PATIENT STATES SHE HAS TO WIGGLE TO MOVE THE HIP BACK INTO PLACE. SHE HAS GONE TO THE HOSPITAL EMERGENCY ROOM TWICE FOR EXTREME PAIN CAUSED BY JOINT MOVEMENT AND SEVERE MUSCLE JERKING IN THE HIP. THE PATIENT IS UNSATISFIED WITH THE SURGEON¿S EXPLANATION OF THE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31808 TRIDENT 10° X3 INSERT 32MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH RKLMKA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other