MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 46MM HUMERAL CONST LINER +2.5

Model Number	320-46-13
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): equinoxe reverse tray adapter plate tray +5 (cat# 320-10-05 / sn# (b)(4).Eq reverse torque defining screw kit (cat# 320-20-00 / sn# (b)(4).
Event or Problem Description
As reported, a (b)(6) y/o male patient has had multiple shoulder surgeries in the past.On (b)(6) 2019 the patient received a total revision of the shoulder.Approximately 6 months after the revision, the patient reported having a clunking sensation while raking leaves in the fall.Exact date of this event is unknown.Patient was still able to move the arm, but surgeon recommended x-rays, which showed something was off and the surgeon believed it was a disassociated liner.During the procedure, it was confirmed the liner was disassociated.The surgeon then increased the size of the liner/tray from a +5 tray 2.5 constrained liner to a +10 tray +0 liner.Explants will be returned to exactech once hospital releases them.Xrays will be sent once received from surgeon.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported may have been the result of incomplete seating of the humeral liner during implantation, forceful contact between the liner and glenoid bone (scapular notching), patient conditions, or a combination of the three, which led to the humeral liner disassociating from the humeral tray.

• Brand Name: EQUINOXE
• Common Device Name: REVERSE 46MM HUMERAL CONST LINER +2.5
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9716945
• Report Number: 1038671-2020-00211
• Device Sequence Number: 16233561
• Product Code: KWT
• UDI-Device Identifier: 10885862086761
• UDI-Public: 10885862086761
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/14/2023
• Device Model Number: 320-46-13
• Device Catalogue Number: 320-46-13
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 07/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention