BEUDAMED
    FDA Adverse Event Injury Summary report: N

    22MM COCR RADIAL HEAD STANDARD HEIGHT/12.5MM-STERILE

    MDR report key: 3971256 · Received July 31, 2014

    Report

    Report Number
    2520274-2014-12898
    Event Type
    Injury
    Date Received
    July 31, 2014
    Report Date
    July 2, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    KWI
    PMA / PMN Number
    PK112030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 HAD A REVISION PROCEDURE DUE TO THE ELBOW BEING UNSTABLE. THE SURGEON IMPLANTED RADIAL HEAD PROSTHESIS IN A PATIENT ON (B)(6) 2014. AFTER SEVERAL DAYS IT BECAME CLEAR THAT THE ELBOW WAS UNSTABLE. THE SURGEON BELIEVES THAT HE MAY HAVE OVERSTUFFED THE JOINT. THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR A REVISION PROCEDURE ON (B)(6) 2014. THE SURGEON REPLACED THE RADIAL HEAD WITH A SMALL DIAMETER HEAD AND LONGER STEM. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446379 22MM COCR RADIAL HEAD STANDARD HEIGHT/12.5MM-STERILE PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER KWI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention