BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUS RVS MINI GLEN CONST

    MDR report key: 6420820 · Received March 21, 2017

    Report

    Report Number
    0001825034-2017-01743
    Event Type
    Injury
    Date Received
    March 21, 2017
    Date of Event
    February 20, 2017
    Report Date
    May 1, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRO CODE: KWR.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO NOT BE REPORTABLE. A REVISION HAS BEEN INDICATED DUE TO PATIENT ANATOMY AND IS NOT RELATED TO A PRODUCT ISSUE. 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). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION DUE TO THE PRODUCTS STILL BEING IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT INITIALLY HAD A CUSTOM CONSTRAINED SHOULDER ARTHROPLASTY IMPLANTED. SUBSEQUENTLY, PATIENT UNDERWENT OPERATION NINE MONTHS POST-IMPLANTATION DUE TO POST-OP X-RAY REVEALING THE LINKED CUSTOM DEVICE HAD SEPARATED FROM THE STEM. THE CUSTOM DEVICE WAS REATTACHED TO THE STEM. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203564 CUS RVS MINI GLEN CONST PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS NI 354470

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R