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 Bacterial Infection (1735)

Event Date 12/02/2020

Event Type  Injury  

Manufacturer Narrative

Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patients underlying condition.Concomitant device(s): 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, 320-20-34, (b)(4), eq rev compress screw lck cap kit, 4.5 x 34mm, 300-01-09, (b)(4), equinoxe, humeral stem primary, press fit 9mm, 320-10-00, (b)(4), equinoxe reverse tray adapter plate tray +0, 320-15-05, (b)(4), eq rev locking screw, 320-01-42, (b)(4), equinoxe reverse 42mm glenosphere, 320-20-26, (b)(4), eq rev compress screw lck cap kit, 4.5 x 26mm, 320-20-18, (b)(4), eq rev compress screw lck cap kit, 4.5 x 18mm, 320-20-00, (b)(4), eq reverse torque defining screw kit.

Event Description

As reported, approximately 3 months postop the initial tsa, this male patient had a wash out arthroscopy of the left shoulder that was done due to infection.Nothing has been revised, taking samples.Patient was last known to be in stable condition following the event.No devices were removed.

• 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: 11035678
• MDR Text Key: 222282615
• Report Number: 1038671-2020-00654
• 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: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• 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: 12/09/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/28/2020
• 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