MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 42MM HUMERAL LINER +0

Model Number 320-42-00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Dislocation (2374)

Event Date 11/30/2020

Event Type  Injury  

Manufacturer Narrative

Based on review of all available information, there is no evidence to suggest that the reported dislocation and revision are related to any design, manufacturing, or patient related issues.The cause of the revision is most likely is related to the patients underlying condition; however, that could not be confirmed.Concomitant device(s): 321-20-00, (b)(4) - equinoxe reverse shoulder drill kit.320-15-01, (b)(4) - eq rev glenoid plate.320-20-34, (b)(4) - eq rev compress screw lck cap kit, 4.5 x 34mm.320-20-46, (b)(4) - eq rev compress screw lck cap kit, 4.5 x 46mm.320-15-05, (b)(4) - eq rev locking screw.320-01-42, (b)(4) - equinoxe reverse 42mm glenosphere.304-22-13, (b)(4) - 12.5mm platform fx stem right.320-10-00, (b)(4) - equinoxe reverse tray adapter plate tray +0.E320-20-00, (b)(4) - eq reverse torque defining screw kit.

Event Description

As reported, in the immediate postop period after the right tsa, this male patient was non-compliant after the initial surgery by not wearing a sling.The patient subsequently dislocated the right shoulder.A revision was completed to change the humeral liner to a constrained one.The patient was last known to be in stable condition following the event.Devices were disposed by the facility.

• Brand Name: EQUINOXE
• Type of Device: REVERSE 42MM HUMERAL LINER +0
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 10943600
• MDR Text Key: 219522451
• Report Number: 1038671-2020-00635
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086693
• UDI-Public: 10885862086693
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-42-00
• Device Catalogue Number: 320-42-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention