BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6MM TI STRAIGHT RADIAL STEM 24MM-STERILE

    MDR report key: 7588054 · Received June 11, 2018

    Report

    Report Number
    2939274-2018-52450
    Event Type
    Injury
    Date Received
    June 11, 2018
    Report Date
    May 17, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    KWI
    UDI-DI
    10886982128034
    PMA / PMN Number
    K112030
    Removal / Correction Number
    Z-1124-2017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. 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 HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 04.402.006S, LOT# 9983203. MANUFACTURING LOCATION: (B)(4), RELEASE TO WAREHOUSE DATE: JUL 12, 2016, EXPIRY DATE: MAY 31, 2021. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION PERFORMED AT CUSTOMER QUALITY ON THE IMAGES PROVIDED CONFIRMED THAT THE STEM OF THE DEVICE BACKED OUT WITH MIGRATION OF HEAD AND STEM UNIT TOWARDS HUMERUS. THIS COMPLAINT CONDITION WAS CONFIRMED. BOTH FUNCTIONAL TEST AND COMPLAINT REPLICATION IS NOT POSSIBLE TO BE PERFORMED AT CUSTOMER QUALITY AS THE DEVICE WAS NOT RETURNED. RELEVANT PRODUCT DRAWINGS WERE REVIEWED AND NO DESIGN ISSUES WERE IDENTIFIED. WHILE NO ROOT CAUSE COULD BE DETERMINED IT IS LIKELY THAT ANY UNINTENDED EXCESSIVE FORCES ENCOUNTERED BY THE DEVICE DURING PATIENT'S POST-OP ACTIVITIES COULD HAVE CONTRIBUTED TO THIS COMPLAINT CONDITION. RELEVANT ACTIONS HAVE BEEN TAKEN TO ADDRESS THE ISSUE. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO ADDITIONAL CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED 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 THAT A PATIENT WAS ORIGINALLY IMPLANTED WITH A 6MM TITANIUM STRAIGHT RADIAL STEM WITH A RADIAL HEAD ON (B)(6) 2016. THE PATIENT WAS REPORTED TO BE PROGRESSING FINE UNTIL RECENTLY WHEN THE PATIENT VISITED THE CLINIC WITH REPORTS OF PAIN IN THE FOREARM. X-RAYS TAKEN SHOW THAT THE STEM OF THE RADIAL HEAD WAS LOOSE. NO REVISION PROCEDURE HAS BEEN PLANNED AT THIS TIME. CONCOMITANT DEVICES: 18MM COCR RADIAL HEAD 2MM HT EXTENSION/13.5MM-STER (PART: 09.402.218S, LOT: 7607087, QUANTITY: 1) THIS REPORT IS FOR A 6MM TI STRAIGHT RADIAL STEM 24MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431826 6MM TI STRAIGHT RADIAL STEM 24MM-STERILE PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER KWI WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.402.006S 9983203 10886982128034

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention