BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20MM COCR RADIAL HEAD 2MM HT EXTENSION/14.0MM-STER

    MDR report key: 4485722 · Received February 4, 2015

    Report

    Report Number
    2520274-2015-10738
    Event Type
    Malfunction
    Date Received
    February 4, 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

    ADDITIONAL NARRATIVE: ADDITIONAL PATIENT IDENTIFIER: (B)(6). EXPIRATION DATE REPORTED AS DECEMBER, 2017. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES NEMCOMED (NOW KNOWN AS AVALIGN TECHNOLOGIES-NEMCOMED) MANUFACTURED THE 20MM COCR RADIAL HEAD 2MM EXTENSION, PART #09.402.220 AND LOT #6905663 FOR (B)(4) PARTS DELIVERED ON DECEMBER 3, 2012 AND PROCESSED ON WORK ORDER #(B)(4). INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE, DATED NOVEMBER 29, 2012, AND WAS INSPECTED AND CONFORMED TO THE SYNTHES FINAL INSPECTION SHEET (B)(4), REVISION ¿A.¿ THE PARTS WERE LABELED, PACKAGED, STERILIZED (PO # (B)(4)) AT STERIGENICS (CORONA) AND RELEASED TO THE WAREHOUSE ON FEBRUARY 8, 2013, WITH EXPIRATION DATE DECEMBER 2017. THERE WERE NO MRR¿S, NCR¿S, 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 ONE RADIAL HEAD, 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. NO OTHER INFORMATION AVAILABLE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4). THIS REPORT IS FOR AN UNKNOWN RADIAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82054 20MM COCR RADIAL HEAD 2MM HT EXTENSION/14.0MM-STER PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER KWI SYNTHES MONUMENT 6905663

    Patients

    Seq Age Sex Outcome Treatment
    1