BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMERAL STEM 9MM

    MDR report key: 5116530 · Received October 1, 2015

    Report

    Report Number
    1220246-2015-00258
    Event Type
    Injury
    Date Received
    October 1, 2015
    Date of Event
    November 1, 2014
    Report Date
    April 29, 2016
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    PMA / PMN Number
    K010124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THIS REPORT WAS PROVIDED BASED ON AN ANNUAL REPORT FROM A CASE STUDY. THE DEVICES WERE NOT AVAILABLE FOR EVALUATION THEREFORE THE EVENT AS PUBLISHED IN THE LITERATURE REVIEW SOURCE COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBERS WERE NOT PROVIDED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. UNKNOWN DEVICE DISPOSITION.

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. THIS IS A FOLLOW-UP SUBMISSION TO REFLECT A CHANGE TO THE DEVICE'S PART NUMBER THAT WAS DISCOVERED DURING A COMPLAINT REVIEW. THE ORIGINAL PART NUMBER WAS AR-9100-05P BUT SHOULD BE AR-9100-09. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THIS REPORT WAS PROVIDED BASED ON AN ANNUAL REPORT FROM A CASE STUDY. THE DEVICES WERE NOT AVAILABLE FOR EVALUATION THEREFORE THE EVENT AS PUBLISHED IN THE LITERATURE REVIEW SOURCE COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBERS WERE NOT PROVIDED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. UNKNOWN DEVICE DISPOSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ANNUAL REPORT OF THE (B)(6) REGISTRY (B)(6) IN A WHITEPAPER PUBLICATION STUDY "DEMOGRAPHICS AND OUTCOMES OF SHOULDER ARTHOPLASTY" THAT THERE WERE 34 CASES INVOLVED IN THE STUDY. RESULTS: 11 PATIENTS SUBSEQUENTLY HAD A REVISION SURGERY WITH THE PRIMARY DIAGNOSIS OF OSTEOARTHRITIS.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ANNUAL REPORT OF THE (B)(6) IN A WHITEPAPER PUBLICATION STUDY "DEMOGRAPHICS AND OUTCOMES OF SHOULDER ARTHROPLASTY" THAT THERE WERE 34 CASES INVOLVED IN THE STUDY. RESULTS: 11 PATIENTS SUBSEQUENTLY HAD A REVISION SURGERY WITH THE PRIMARY DIAGNOSIS OF OSTEOARTHRITIS. FOLLOW-UP INFORMATION: IT WAS DISCOVERED DURING A COMPLAINT REVIEW THAT THE ORIGINAL PART # AR-9100-05P WAS INCORRECT. THE DEVICE PART NUMBER FROM THE ((B)(6)) STUDY WAS AR-9100-09.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650944 HUMERAL STEM 9MM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other