BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE SEGMENTAL REVISION SYSTEM 71MM TUMOR BODY

    MDR report key: 6537034 · Received May 2, 2017

    Report

    Report Number
    0001825034-2017-02969
    Event Type
    Injury
    Date Received
    May 2, 2017
    Date of Event
    March 31, 2017
    Report Date
    January 25, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWT
    PMA / PMN Number
    PK111746
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCT-HUMERAL HEAD CATALOG#: 211256 LOT# 777400. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANT DATE - EXACT DATE IS UNKNOWN, HOWEVER IT IS KNOWN IT WAS 3-4 MONTHS PRIOR TO THE REVISION PROCEDURE. CUSTOMER HAS NOT INDICATED WHETHER OR NOT THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-02967.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE PROXIMAL BODY WAS VISUALLY EXAMINED. THERE IS FRETTING NOTED IN THE BOTTOM OF THE FEMALE TAPER WHERE THE HEAD IS TO BE ASSEMBLED. THE PRESENCE OF FRETTING CAN BE AN INDICATION THAT THE HEAD WAS NOT FULLY SEATED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT COMPREHENSIVE SRS SHOULDER REVISION APPROXIMATELY SIX (6) MONTHS POST-IMPLANTATION DUE TO DISASSOCIATION OF THE HUMERAL HEAD FROM THE PROXIMAL BODY. THE PROXIMAL BODY AND HEAD WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT COMPREHENSIVE SRS SHOULDER REVISION APPROXIMATELY 3-4 MONTHS POST-IMPLANTATION DUE TO DISASSOCIATION OF THE HUMERAL HEAD FROM THE PROXIMAL BODY. THE PROXIMAL BODY AND HEAD WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319516 COMPREHENSIVE SEGMENTAL REVISION SYSTEM 71MM TUMOR BODY PROSTHESIS, SHOULDER KWT BIOMET ORTHOPEDICS N/A 340250

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization| R