BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8MM TI STRAIGHT RADIAL STEM 28MM-STERILE

    MDR report key: 4476997 · Received February 2, 2015

    Report

    Report Number
    2520274-2015-10716
    Event Type
    Malfunction
    Date Received
    February 2, 2015
    Report Date
    January 20, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KWI
    PMA / PMN Number
    PK112030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED: NEMCOMED (NOW KNOWN AS AVALIGN TECHNOLOGIES-NEMCOMED) MANUFACTURED THE 8MM TI STRAIGHT RADIAL STEM, PART 04.402.008 AND LOT 7012217. INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE AND WAS INSPECTED AND CONFORMED TO THE SYNTHES FINAL INSPECTION SHEET. THE PARTS WERE LABELED, PACKAGED, STERILIZED AT STERIGENICS ((B)(4)) AND RELEASED TO THE WAREHOUSE ON DECEMBER 12, 2012, WITH EXPIRATION DATE OCTOBER 2017. THERE WERE NO MATERIAL REVIEW REPORTS, NON-CONFORMANCE REPORTS, OR COMPLAINT RELATED ISSUES WITH THIS LOT. 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

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR A RADIAL STEM, CATALOG AND LOT NUMBERS UNKNOWN. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 ON AN UNKNOWN DATE POSTOPERATIVE X-RAYS REVEALED RADIAL HEAD PROSTHESIS LOOSENING. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4). THIS REPORT IS FOR AN UNKNOWN RADIAL STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76365 8MM TI STRAIGHT RADIAL STEM 28MM-STERILE PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER KWI SYNTHES MONUMENT 7012217

    Patients

    Seq Age Sex Outcome Treatment
    1