BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER - HUMERAL STEM 15MM

    MDR report key: 2960982 · Received February 14, 2013

    Report

    Report Number
    0002249697-2013-00671
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWS
    PMA / PMN Number
    K955731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER SHOULDER DEVICES WERE ALSO LISTED IN THIS REPORT:SHOULDER - HUMERAL HEAD 45MMX18MM, CAT# 5350-4518, LOT# MJENK7.#7 PEGGED GLENOID, CAT# UNK, LOT# UNK.IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION.ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A HUMERAL STEM WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: A VISUAL INSPECTION WAS PERFORMED AND THERE WAS DAMAGE DUE TO EXPLANTATION ON THE RETURNED DEVICE. NO DISCREPANCIES WERE NOTED. MEDICAL RECORDS RECEIVED AND EVALUATION: REVISION OPERATIVE REPORT AND X-RAY WAS RECEIVED. THE OPERATIVE REPORT STATED THAT THE WHITE BLOOD CELL COUNT WAS ELEVATED AND THEREFORE LED TO THE REMOVAL OF COMPONENTS. DEVICE HISTORY REVIEW: ALL DEVICES WERE ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE LOT AND STERILE LOT REFERENCED. THERE WERE NO OTHER REPORTED EVENTS FOR THE LOT AND THERE WAS A PREVIOUS REPORTED EVENT FOR THE STERILE LOT. CONCLUSIONS: THE SOURCE OF THE INFECTION COULD NOT BE DETERMINED AS PATIENT INFORMATION, CLINICAL HISTORY, AND RESULTS OF BLOODWORK 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.

    Description of Event or Problem · 1

    HUMERAL STEM HAD SUBSIDED. PATIENT WAS INFECTED SO HUMERAL STEM, HUMERAL HEAD AND GLENOID WERE ALL REMOVED. NO REPLACEMENT DEVICE WAS IMPLANTED AT THAT TIME.

    Description of Event or Problem · 1

    HUMERAL STEM HAD SUBSIDED. PATIENT WAS INFECTED SO HUMERAL STEM, HUMERAL HEAD AND GLENOID WERE ALL REMOVED. NO REPLACEMENT DEVICE WAS IMPLANTED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65722 SHOULDER - HUMERAL STEM 15MM IMPLANT KWS STRYKER ORTHOPAEDICS-MAHWAH MJP7T7

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention