BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7MM TI STRAIGHT RADIAL STEM 26MM-STERILE

    MDR report key: 6848720 · Received September 7, 2017

    Report

    Report Number
    1719045-2017-10892
    Event Type
    Injury
    Date Received
    September 7, 2017
    Date of Event
    August 16, 2017
    Report Date
    August 16, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KWI
    PMA / PMN Number
    H10
    Removal / Correction Number
    Z-1124-2017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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 · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED PAIN AND MECHANICAL BLOCK. IT REPORTED THAT A REVISION SURGERY TO REMOVE THE IMPLANTS WAS PERFORMED. IT WAS NOTED THAT EXCISION OF THE RADIAL HEAD WITHOUT REPLACEMENT IMPLANTS HAD ALWAYS BEEN CONSIDERED AS A TREATMENT OPTION FOR THE RADIAL HEAD FRACTURE AS THE RADIAL HEAD IS A SECONDARY STABILIZER. THE PATIENT CONTINUES TO HAVE A FUNCTIONAL ELBOW.

    Additional Manufacturer Narrative · 1

    APPROPRIATE ACTIONS HAVE BEEN INITIATED/TAKEN TO ADDRESS THE MATTER. THE COMPLAINT IS CONFIRMED AS THE RECEIVED X-RAY PICTURES SHOW THE LOOSENED AND DISPLACED IMPLANTS. 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

    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 USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6), PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. (B)(4). THIS REPORT IS FOR RADIO HEAD /UNKNOWN LOT NUMBER, UNKNOWN XXMM COCR RADIAL HEAD (STERILE OR UNSTERILE, SIZE UNKNOWN, UNKNOWN IF STANDARD OR EXTENSION). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). PMA#: K112030. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND 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 THAT THE ACTUAL PRODUCT CODE IS A SET OF IMPLANTED RADIAL HEAD ELEMENT (SIZE UNKNOWN) AND RADIAL STEM ELEMENT (SIZE UNKNOWN) FROM DEPUY SYNTHES RADIAL HEAD PROSTHESIS SYSTEM, WHICH WAS VOLUNTARILY RECALLED. NO SURGICAL DELAY IS REPORTED. NO INFORMATION AVAILABLE ABOUT PATIENT CONDITION AND OUTCOME. IMPLANT WAS LOOSENING (EXACT SAME PROBLEM AS PER RECALL) AND SECONDARY FRACTURE. DECREASED ROM. COMPLAINT INVOLVES 2 PARTS. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628430 7MM TI STRAIGHT RADIAL STEM 26MM-STERILE PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER KWI SYNTHES MONUMENT 6793314

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention