BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

    MDR report key: 6171115 · Received December 13, 2016

    Report

    Report Number
    2520274-2016-15672
    Event Type
    Injury
    Date Received
    December 13, 2016
    Report Date
    November 22, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    KWI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. ADDITIONAL NARRATIVE: (B)(4). THIS REPORT IS FOR AN UNKNOWN RADIAL HEAD PROSTHESIS/ UNKNOWN QUANTITY/ UNKNOWN LOT. UNKNOWN PART NUMBER, UDI UNAVAILABLE. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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

    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. CORRECTED DATE RECEIVED BY MFR DATE FROM 13-JAN-2017 TO 06-JAN-2017. 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

    (B)(4). RADIAL HEAD ARTHROPLASTY IS A COMMON TREATMENT FOR COMMINUTED RADIAL HEAD AND RADIAL NECK FRACTURES THAT ARE NOT AMENABLE TO REDUCTION AND FIXATION. REPORTED OUTCOMES HAVE BEEN SATISFACTORY WITH A COMMON COMPLICATION BEING LOOSENING OF THE PROSTHESIS. THE PURPOSE OF THIS STUDY IS TO REVIEW THE RADIOGRAPHIC OUTCOMES OF ALL RADICAL HEAD PROSTHESIS PLACED AT ONE LEVEL 1 TRAUMA CENTER AND TO COMPARE THE RATE OF PERIPROSTHETIC LUCENCY, OSTEOLYSIS, PERIOSTEAL REACTION, AND THE NEED FOR REOPERATION BETWEEN TWO IMPLANTS. THE STUDY INVOLVES A RETROSPECTIVE REVIEW OF ALL PATIENTS WHO RECEIVED A RADIAL HEAD ARTHROPLASTY FOR FRACTURE OF THE RADIAL HEAD OR RADIAL NECK FROM (B)(6) 2010 TO (B)(6) 2015. 40 PRESS-FIT RADIAL HEAD PROSTHESIS WERE IMPLANTED INTO 39 PATIENTS. FOURTEEN ELBOWS IN 14 PATIENTS RECEIVED THE SYNTHES RADIAL HEAD PROSTHESIS, AND 26 ELBOWS IN 25 PATIENTS RECEIVED THE COMPETITOR PRODUCT. THE RATE OF OSTEOLYSIS WAS 64% IN THE SYNTHES IMPLANT. THIS MET STATISTICAL SIGNIFICANCE (P=0.0004). THERE WERE 4 REOPERATIONS IN THE PATIENT WHO RECEIVED THE SYNTHES IMPLANT. ALL REOPERATIONS INVOLVED REMOVAL OF THE PROSTHESIS. ONE PATIENT WITH THE SYNTHES IMPLANT WENT ON TOTAL ELBOW ARTHROPLASTY. THIS REPORT IS FOR 1 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN RADIAL HEAD PROSTHESIS. THIS REPORT IS FOR AN UNKNOWN PATIENT WHO EXPERIENCED LOOSENING OF THE PROSTHESIS, THREE UNKNOWN PATIENTS WITH REMOVAL OF RADIAL HEAD PROSTHESIS, AND ONE PATIENT WITH TOTAL ELBOW ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822618 PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER KWI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention