BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 10° X3 INSERT 36MM ID

    MDR report key: 3825232 · Received May 21, 2014

    Report

    Report Number
    0002249697-2014-01904
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICES WERE ALSO LISTED IN THIS REPORT: DELTA C-TAPER HEAD 36MM +5; CAT# 18-3605; LOT# 44801901. TI SLEEVE FOR ALUMINA HEAD; CAT# 17-0000E; LOT# MMP870. MOD REV 21MM STD CONE TRIAL COMPONENT LEVEL 9006-2-021; CAT# 6278-1-021; LOT# 43488103. DELTA V-40 CERAMIC HEAD 36/+5; CAT# 6570-0-236; LOT# 43902201. MOD CON DIST STEM 19 X 155 MM; CAT# 6276-7-019; LOT# CAXN633A. UNKNOWN SCREWS; CAT# UNK LOT# UNK. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION. . AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE HOSPITAL AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION 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.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING INFECTION INVOLVING A TRIDENT 10° X3 INSERT 36MM ID WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION AND RESULTS: A PHOTO PROVIDED FOR ANALYSIS OF THE TRIDENT 10° X3 INSERT 36MM ID SHOWED A SINGLE VIEW OF THE EXPLANTED INSERT. THE INSERT IS INTACT. ONLY THE INNER SURFACE CAN BE VISUALIZED COVERED IN BLOOD STAINS THROUGHOUT. NO FURTHER ANALYSIS CAN BE OBTAINED FROM THE PHOTO PROVIDED. MEDICAL RECORDS RECEIVED AND EVALUATION: THE PROVIDED MEDICAL INFORMATION WAS SUBMITTED TO A CONSULTING CLINICIAN WHO DEEMED IT INSUFFICIENT FOR A MEDICAL REVIEW. THE REPORTED EVENT COULD NOT BE CONFIRMED WITH THE PROVIDED MEDICAL RECORDS AND X-RAYS. DEVICE HISTORY REVIEW: INDICATED ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT OR STERILE LOT REFERENCED. CONCLUSIONS: THE SOURCE OF THE INFECTION COULD NOT BE DETERMINED AS THE PROVIDED MEDICAL INFORMATION WAS SUBMITTED TO A CONSULTING CLINICIAN WHO DEEMED IT INSUFFICIENT FOR A MEDICAL REVIEW. FURTHER MEDICAL RECORDS SUCH AS OP REPORTS, PATHOLOGY REPORT AND CONFIRMATION OF THE INDICATION FOR REVISION ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INFECTION IS MOST LIKELY A RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE IN THE HEALTHCARE FACILITY SETTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THIS PATIENT'S RIGHT HIP WAS PREVIOUSLY REVISED FOR REJUVENATE IMPLANTS THAT WERE IMPLANTED DURING PRIMARY SURGERY ON (B)(6) 2011. ON (B)(6) 2013 DR. REVISED REJUVENATE TO RESTORATION MODULAR. ON (B)(6) 2013 DR. PERFORMED AN I & D. THE PATIENTS IMPLANTS HAVE NOW BEEN REMOVED DUE TO INFECTION AND AN ANTIBIOTIC SPACER HAS BEEN IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THIS PATIENT'S RIGHT HIP WAS PREVIOUSLY REVISED FOR REJUVENATE IMPLANTS THAT WERE IMPLANTED DURING PRIMARY SURGERY ON (B)(6) 2011. ON (B)(6) 2013 DR. (B)(6) REVISED REJUVENATE TO RESTORATION MODULAR. ON (B)(6) 2013 DR. (B)(6) PERFORMED AN I & D. THE PATIENTS IMPLANTS HAVE NOW BEEN REMOVED DUE TO INFECTION AND AN ANTIBIOTIC SPACER HAS BEEN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303292 TRIDENT 10° X3 INSERT 36MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MMPLW3

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention