BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7MM TI STRAIGHT RADIAL STEM 26MM-STERILE

    MDR report key: 4474635 · Received February 2, 2015

    Report

    Report Number
    1719045-2015-10082
    Event Type
    Injury
    Date Received
    February 2, 2015
    Report Date
    January 20, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KWI
    PMA / PMN Number
    PK112030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES (B)(6) TECHNOLOGIES-(B)(6) MANUFACTURED THE 7MM TI STRAIGHT RADIAL STEM, PART #04.402.007 AND LOT #7133464 ON PO #(B)(4) DATED (B)(6) 2013 FOR (B)(4) PARTS PROCESSED ON WORK ORDER #(B)(4). INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE, DATED (B)(6) 2013 AND WAS INSPECTED AND CONFORMED TO SYNTHES FINAL INSPECTION SHEET (B)(6). THE PARTS WERE LABELED, PACKAGED, STERILIZED (PO #(B)(4)) AT STERIGENICS (CORONA) AND RELEASED TO THE WAREHOUSE ON (B)(6) 2013, WITH EXPIRATION DATE (B)(6) 2018. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED POSTOPERATIVELY THE PATIENT WAS EXPERIENCING PAIN ASSOCIATED WITH THE RADIAL PROSTHESIS. THE ORIGINAL RADIAL PROSTHESIS WAS IMPLANTED ON (B)(6) 2014 AND THE SURGERY WENT AS PLANNED. ON (B)(6) 2014 POSTOPERATIVE X-RAYS REVEALED OSTEOLYSIS AND LOOSENING OF THE RADIAL PROSTHESIS. ADDITIONAL POSTOPERATIVE X-RAYS HAVE BEEN REQUIRED TO MONITOR HEALING. THE SURGEON IS PLANNING ON REVISING THE PATIENT IN THE NEAR FUTURE. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75209 7MM TI STRAIGHT RADIAL STEM 26MM-STERILE PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER KWI SYNTHES MONUMENT 7133464

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention