BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REUNION HA FRACTURE STEM 9MM

    MDR report key: 4243332 · Received November 11, 2014

    Report

    Report Number
    0002249697-2014-04229
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 17, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    HSD
    PMA / PMN Number
    K070963
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS REPORTED FOR THE REPORTED MANUFACTURING LOT. PATIENT DETAILS WERE REVIEWED AND NO INDICATION WAS FOUND THAT THE EVENT WAS RELATED TO DEVICE DESIGN, MATERIALS, OR MANUFACTURING. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION BECAUSE IT WAS RETAINED BY THE HOSPITAL. THE LOT CODE PROVIDED, T6S104893C, WAS INVALID. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    REVISION SURGERY TO REMOVE SHOULDER PROSTHESIS. REMOVAL OF REUNION FRACTURE STEM AND HEAD. ADDITIONALLY REPORTED BY THE SALES REP ON 10/24/2014: THE MEDICAL REASON FOR REMOVAL WAS THE STEM AND HEAD WERE TOO HIGH AND ROTATOR CUFF COULD NOT FUNCTION PROPERLY OR NON EXISTENT. ALSO STEM WAS IN A LOT OF VALGUS. PATIENT NEEDED A TOTAL REVERSE SHOULDER.

    Description of Event or Problem · 1

    REVISION SURGERY TO REMOVE SHOULDER PROSTHESIS. REMOVAL OF REUNION FRACTURE STEM AND HEAD.ADDITIONALLY REPORTED BY THE SALES REP ON (B)(6) 2014: THE MEDICAL REASON FOR REMOVAL WAS THE STEM AND HEAD WERE TOO HIGH AND ROTATOR CUFF COULD NOT FUNCTION PROPERLY OR NON EXISTENT. ALSO STEM WAS IN A LOT OF VALGUS. PATIENT NEEDED A TOTAL REVERSE SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726039 REUNION HA FRACTURE STEM 9MM IMPLANT HSD STRYKER ORTHOPAEDICS-MAHWAH T6S104893C

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R