BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE VRS GLENOID W/FAST GUIDES

    MDR report key: 6663924 · Received June 23, 2017

    Report

    Report Number
    0001825034-2017-04218
    Event Type
    Injury
    Date Received
    June 23, 2017
    Date of Event
    May 17, 2017
    Report Date
    August 18, 2022
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PHX
    PMA / PMN Number
    PK152754
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT CLASSIFICATION CODE = PHX. UDI NUMBER - (B)(4). THE COMPLAINT DEVICE IS NOT EXPECTED FOR RETURN CURRENTLY, BUT A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. 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). THE FOLLOWING REPORT IS SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: COMP RVS CNTRL 6.5 X 30 MM ST/RST LOT#911190 ITEM#115396. THE REPORTED EVENT COULD NOT BE CONFIRMED BASED ON LIMITED INFORMATION RECEIVED. NO DEVICES RETURNED; THEREFORE, NO VISUAL OR DIMENSIONAL INSPECTIONS WERE CONDUCTED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. FINAL DESIGN NOTICE OF THE PATIENT SPECIFIC PRODUCT WAS APPROVED BY THE SURGEON. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2017-09751.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL SURGERY WITH A COMPREHENSIVE VRS SHOULDER SYSTEM. DURING THE PROCEDURE, AS THE DOCTOR DRILLED AND IMPLANTED PERIPHERAL SCREWS TO SECURE THE IMPLANT, HE WAS UNABLE TO IMPLANT THE CENTRAL SCREW, EITHER DUE TO THE SCREW HOLE OR THE GLENOID COMPONENT ITSELF. THE SURGEON ALSO TRIED A SECOND TIME, WITHOUT SUCCESS. ULTIMATELY, THE COMPONENT WAS IMPLANTED WITHOUT THE CENTRAL SCREW. IT WAS FURTHER REPORTED THAT THE CENTRAL GUIDE DOES NOT FIT WELL INSIDE THE CENTRAL HOLE OF THE CUSTOM GLENOID, FURTHERMORE THE GUIDE THAT COMES WITH THE GLENOID IS SITUATED ON THE WRONG SIDE MAKING USE DIFFICULT BECAUSE OF EXPOSURE WITHIN THE SHOULDER, THUS CONTRIBUTING TO THIS ISSUE. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION HOWEVER FURTHER INFORMATION IS NOT AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL SURGERY WITH A COMPREHENSIVE VRS SHOULDER SYSTEM. DURING THE PROCEDURE, AS THE DOCTOR DRILLED AND SECURED THE PERIPHERAL SCREW HOLES, HE WAS UNABLE TO IMPLANT THE CENTRAL SCREW, EITHER DUE TO THE DRILLED HOLE OR THE GLENOID COMPONENT ITSELF. THE SURGEON ALSO TRIED A SECOND TIME, WITHOUT SUCCESS. ULTIMATELY, THE COMPONENT WAS IMPLANTED WITHOUT THE CENTRAL SCREW. IT WAS FURTHER REPORTED THAT THE CENTRAL GUIDE DOES NOT FIT WELL INSIDE THE CENTRAL HOLE OF THE CUSTOM GLENOID, FURTHERMORE THE GUIDE THAT COMES WITH THE GLENOID IS SITUATED ON THE WRONG SIDE MAKING USE DIFFICULT BECAUSE OF EXPOSURE WITHIN THE SHOULDER, THUS CONTRIBUTING TO THIS ISSUE. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION HOWEVER FURTHER INFORMATION IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445624 COMPREHENSIVE VRS GLENOID W/FAST GUIDES SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX BIOMET ORTHOPEDICS N/A 872890

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Other