BEUDAMED
    FDA Adverse Event Injury Summary report: N

    22MM COCR RADIAL HEAD 6MM HT EXTENSION/18.5MM-STER

    MDR report key: 7379544 · Received March 28, 2018

    Report

    Report Number
    2939274-2018-51286
    Event Type
    Injury
    Date Received
    March 28, 2018
    Report Date
    April 2, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    KWI
    UDI-DI
    10886982132772
    PMA / PMN Number
    K112030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE HISTORY RECORDS REVIEW WAS ATTEMPTED: DEVICE HISTORY LOT - PART #: 09.402.422S, LOT#: 6905326 (STERILE) - 22MM COCR RADIAL HEAD 4MM HT EXTENSION/16.5 MM - STERILE. PART NUMBER PROVIDED 09.402.622S IS INVALID FOR LOT 6905326. IT SHOULD BE 09.402.422S. DHR HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. INVESTIGATION SUMMARY: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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

    CORRECTED DATA: MANUFACTURE DATE IS UNKNOWN. DHR COULD NOT BE COMPLETED AS LOT NUMBER DOES NOT MATCH PART NUMBER. 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 UNDERWENT REMOVAL OF A RADIAL HEAD AND STEM PROSTHESIS ON (B)(6) 2018. THE REMOVAL WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. THE PATIENT WAS NOT REVISED TO ANYTHING FOLLOWING THE PROCEDURE. IT IS UNKNOWN WHY THE DEVICES WERE REMOVED. IT WAS REPORTED THAT IT MAY HAVE BEEN DUE TO A PATIENT'S COMPLAINT OF PAIN. THIS REPORT INVOLVES 2 DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221848 22MM COCR RADIAL HEAD 6MM HT EXTENSION/18.5MM-STER PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER KWI WRIGHTS LANE SYNTHES USA PRODUCTS LLC 09.402.622S 6905326 10886982132772

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention