BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    24MM COCR RADIAL HEAD STANDARD HEIGHT/13.0MM-STERILE

    MDR report key: 6420442 · Received March 21, 2017

    Report

    Report Number
    2520274-2017-10950
    Event Type
    Malfunction
    Date Received
    March 21, 2017
    Report Date
    February 28, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KWI
    PMA / PMN Number
    K112030
    Removal / Correction Number
    Z-1124-2017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT BMI IS (B)(6). UDI: (B)(4). 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

    MANUFACTURER WAS UPDATED IN (B)(4). COMPLAINT WAS REVIEWED AND DETERMINED TO BE A PART OF RECALL UPDATED. CORRECTED DATA: UDI# (B)(4). EXPIRATION DATE UNKNOWN (10) LOT NUMBER UNKNOWN. 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

    (B)(6). DATE OF EVENT IS UNKNOWN. THIS REPORT IS FOR ONE (1) UNKNOWN 24 MM RADIAL HEAD. PART AND LOT NUMBER IS UNKNOWN. WITHOUT A VALID PART AND LOT NUMBER, UDI IS NOT AVAILABLE. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE (510K): UNKNOWN. (B)(4). INTERNAL REVIEW OF THE PROVIDED X-RAYS REVEALED THAT THE RADIOGRAPHS SHOW AN EXCELLENT PLACEMENT OF THE RADIAL HEAD PROSTHESIS (RHP). ONE SET IS EARLY ON SHOWS NO RADIOLUCENCY OR ¿HALOING¿. THE MORE RECENT SET (NO DATES ON FILMS) SHOW SLIGHT RADIOLUCENCY. 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

    AFTER THE ORIGINAL PROCEDURE ON (B)(6) 2016, AS THE PATIENT WENT THROUGH PHYSICAL THERAPY AND FOLLOW-UP VISITS, HIS FOREARM AND ELBOW PAIN WORSENED. ON (B)(6) 2017, HE WAS TOLD THAT THE X-RAYS SHOWED THE IMPLANT IN HIS ARM HAD LOOSENED. HE UNDERWENT A HARDWARE REMOVAL AND REVISION ON (B)(6) 2017. THE PATIENT CONTINUES TO UNDERGO PHYSICAL THERAPY AND FOLLOW-UP VISITS WITH HIS SURGEON, AND HIS PAIN CONTINUES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT RADIAL HEAD FRACTURE REPAIR WITH A RADIAL HEAD PROSTHESIS ON (B)(6) 2016. ON (B)(6) 2017, THE PATIENT PRESENTED WITH COMPLAINTS OF LEFT FOREARM PAIN. X-RAYS TAKEN THAT DAY SHOWED "HALOING" (LUCENCY) AROUND THE RADIAL HEAD PROSTHESIS STEM. LAB RESULTS SHOWED NO SIGN OF INFECTION. A HARDWARE REMOVAL PROCEDURE WAS PERFORMED ON (B)(6) 2017 SUCCESSFULLY. THIS REPORT IS FOR ONE (1) UNKNOWN 24 MM RADIAL HEAD. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205251 24MM COCR RADIAL HEAD STANDARD HEIGHT/13.0MM-STERILE PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER KWI SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention