BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7MM TI CURVED RADIAL STEM 42MM-STERILE

    MDR report key: 4485725 · Received February 4, 2015

    Report

    Report Number
    2520274-2015-10739
    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

    (B)(6). EXPIRATION DATE REPORTED AS NOVEMBER, 2017. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES NEMCOMED (NOW KNOWN AS AVALIGN TECHNOLOGIES-(B)(4)) MANUFACTURED THE 7MM TI CURVED RADIAL STEM, PART #04.402.027 AND LOT #7012309 ON PO #(B)(4) FOR (B)(6) PARTS DELIVERED ON (B)(6) 2012 AND PROCESSED ON WORK ORDER #(B)(4). INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE, DATED NOVEMBER 16, 2012 AND WAS INSPECTED AND CONFORMED TO SYNTHES FINAL INSPECTION SHEET (B)(4), REVISION ¿B¿. THE PARTS WERE LABELED ((B)(6) PARTS WERE SPLIT TO LOT #7123555 FOR PROCESSING ON WORK ORDER (B)(4) AT LABELING), PACKAGED, STERILIZED (PO #(B)(4)) AT (B)(6) AND RELEASED TO THE WAREHOUSE ON (B)(6) 2013, WITH EXPIRATION DATE NOVEMBER 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 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. NO OTHER INFORMATION AVAILABLE. 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
    82055 7MM TI CURVED RADIAL STEM 42MM-STERILE PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER KWI SYNTHES MONUMENT 7012309

    Patients

    Seq Age Sex Outcome Treatment
    1