BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

    MDR report key: 6212152 · Received December 29, 2016

    Report

    Report Number
    2520274-2016-15789
    Event Type
    Malfunction
    Date Received
    December 29, 2016
    Report Date
    December 2, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    KWI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR ONE (1) UNKNOWN RADIAL STEM. DEVICE IS NOT REPORTED TO HAVE EXPLANTED YET. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THIS REPORT IS FOR ONE (1) UNKNOWN RADIAL STEM. PMA/510(K) NUMBER IS NOT AVAILABLE. DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. 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

    UPDATE: INTERNAL REVIEW WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES INDICATES THAT THE: PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED. THESE RADIOGRAPHS DO SHOW MILD TO MODERATE LUCENCY OF WHAT APPEARS TO BE A SYNTHES RHP. BASED ON THE INFORMATION AVAILABLE, THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT UNDERWENT INITIAL SURGERY AND WAS TREATED WITH RADIAL HEAD IMPLANTS. ON (B)(6) 2016, UPON A ROUTINE FOLLOW UP APPOINTMENT, IT WAS FOUND VIA X-RAYS THAT THE STEM OF THE IMPLANT APPEARS LOOSE. THERE ARE NO COMPLAINTS FROM THE PATIENT AT THE MOMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN RADIAL HEAD (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) UNKNOWN RADIAL STEM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861949 PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER KWI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR ONE (1) UNKNOWN RADIAL HEAD