BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXETER X3 RIMFIT ID36 OD52

    MDR report key: 5761814 · Received June 30, 2016

    Report

    Report Number
    0002249697-2016-02150
    Event Type
    Injury
    Date Received
    June 30, 2016
    Date of Event
    June 7, 2016
    Report Date
    June 7, 2016
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K111848
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: SECUR-FIT MAX 132 HIP STEM #8; CAT# 6051-0830S; LOT# MNH2P9. C-TAPER COCR LFIT HEAD 36MM/+7.5MM; CAT# 06-3675; LOT# MKPDN7. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A EXETER CUP WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: THE PROVIDED MEDICAL INFORMATION WAS SUBMITTED TO A CONSULTING CLINICIAN WHO DEEMED IT INSUFFICIENT FOR A MEDICAL REVIEW. DEVICE HISTORY REVIEW: ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT AND STERILE LOT. CONCLUSIONS: THE SOURCE OF THE INFECTION COULD NOT BE DETERMINED AS PATIENT INFORMATION, CLINICAL HISTORY, AND RESULTS OF BLOOD WORK FOR INFECTION WERE NOT PROVIDED. 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. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND/OR INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    PATIENT HAS INFECTED LEFT HIP, REMOVED ZIMMER CAGE, STRYKER STEM AND HEAD, IMPLANTED ANTIBIOTIC SPACER.

    Description of Event or Problem · 1

    PATIENT HAS INFECTED LEFT HIP, REMOVED ZIMMER CAGE, STRYKER STEM AND HEAD, IMPLANTED ANTIBIOTIC SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417196 EXETER X3 RIMFIT ID36 OD52 HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS. JDI STRYKER ORTHOPAEDICS-MAHWAH LDF515

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention