BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM TI STRAIGHT RADIAL STEM 32MM-STERILE

    MDR report key: 6573213 · Received May 17, 2017

    Report

    Report Number
    1719045-2017-10477
    Event Type
    Injury
    Date Received
    May 17, 2017
    Report Date
    April 19, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KWI
    PMA / PMN Number
    K112030
    Removal / Correction Number
    Z-1124-2017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE: 28-FEB-2018. (B)(4). EXPLANT DATE IS NOT APPLICABLE AS REVISION SURGERY IS NOT SCHEDULED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT NUMBER 7012268. MANUFACTURING LOCATION: SUPPLIER (B)(4). PACKAGED BY: (B)(4). DATE OF MANUFACTURE: 29-MAR-2013. EXPIRATION DATE: 28-FEB-2018. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OR STERILIZATION OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OR STERILIZATION OF THE SUBJECT DEVICE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    COMPLAINT WAS REVIEWED AND DETERMINED TO BE A PART OF RECALL. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS STATEMENT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD ORIGINAL SURGERY ON (B)(6) 2014 FOR A PROCEDURE USING THE RADIAL HEAD PROSTHESIS (RHP). PATIENT WAS IMPLANTED WITH ONE (1) RADIAL HEAD IMPLANT AND ONE (1) RADIAL STEM IMPLANT. ON AN UNKNOWN DATE POST-OPERATIVELY, THE RHP DEVICE WAS OBSERVED THRU X-RAY AS BEING LOOSE. ALSO, PATIENT IS REPORTED TO HAVE OSTEOLYSIS AROUND THE BONE AND IMPLANT. REVISION SURGERY HAS NOT BEEN SCHEDULED. SURGEON IS WAITING FOR PATIENT DECISION. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354985 10MM TI STRAIGHT RADIAL STEM 32MM-STERILE PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER KWI SYNTHES MONUMENT 7012268

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention