BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9MM TI STRAIGHT RADIAL STEM 30MM-STERILE

    MDR report key: 6926553 · Received October 7, 2017

    Report

    Report Number
    1719045-2017-11029
    Event Type
    Malfunction
    Date Received
    October 7, 2017
    Report Date
    September 21, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KWI
    PMA / PMN Number
    K112030
    Removal / Correction Number
    Z-1124-2017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PATIENT IDENTIFIER: (B)(6). PATIENT WEIGHT NOT AVAILABLE FOR REPORTING. DATE OF DEVICE LOOSENING IS NOT KNOWN. (B)(4). DEVICE WAS NOT EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW. PART NUMBER: 04.402.009S. SYNTHES LOT NUMBER: 7013305. SUPPLIER LOT NUMBER: N/A. RELEASE TO WAREHOUSE DATE: 18-MAY-2013. EXPIRATION DATE: 30-APR-2018. MANUFACTURED BY SYNTHES (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    UPDATE TO EVENT. 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. APPROPRIATE ACTIONS HAVE BEEN INITIATED/TAKEN TO ADDRESS THE MATTER. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED PATIENT WAS IMPLANTED WITH THE RADIAL HEAD PROSTHESIS ON (B)(6) 2016. X-RAY TAKEN DURING THE ONE-YEAR FOLLOW UP REVEALED THE DEVICE IS LOOSENING. PATIENT REPORTS NO PAIN, SOME OCCASIONAL CLICKING, STABLE ELBOW, VERY GOOD RANGE OF MOTION (ROM), WORKING WITH NO PROBLEM. NO PATIENT HARM REPORTED, PATIENT CONDITION REPORTED AS STABLE. DEVICES REMAIN IMPLANTED. THIS REPORT IS FOR ONE (1) 9MM STRAIGHT RADIAL STEM 30MM. THIS IS REPORT 1 OF 2 FOR COM-(B)(4).

    Description of Event or Problem · 1

    NO ACTION HAS YET BEEN TAKEN AND NO ADDITIONAL MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. SURGEON WILL CONTINUE TO OBSERVE PATIENT CONDITION THROUGH FOLLOW UP VISITS.

    Description of Event or Problem · 1

    THE PATIENT CONDITION IS WELL AND STABLE AND NO NEED AND NO PLANS FOR REVISION, PATIENT IS ON FOLLOW UPS. FURTHER INTERVENTION WILL ONLY DEPEND ON FUTURE FOLLOW UP ON PATIENT CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706067 9MM TI STRAIGHT RADIAL STEM 30MM-STERILE PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER KWI SYNTHES MONUMENT 7013305

    Patients

    Seq Age Sex Outcome Treatment
    1