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

Model Number	320-42-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	04/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant device(s): 300-30-12, 5844380 - equinoxe preserve stem 12mm.320-02-42, 6709501 - rs expanded glenosphere 42mm, +4mm offset.320-10-00, 6763200 - equinoxe reverse tray adapter plate tray +0.320-15-05, 6832873 - eq rev locking screw.320-20-00, 6789863 - eq reverse torque defining screw kit.320-15-08, 6552558 - sup/post aug plate, r rs glenoid baseplate.320-20-38, 6403533 - eq rev compress screw lck cap kit, 4.5 x 38mm.320-20-38, s126143 - eq rev compress screw lck cap kit, 4.5 x 38mm.320-20-30, s093392 - eq rev compress screw lck cap kit, 4.5 x 30mm.
Event or Problem Description
As reported, this male patient had issues with an r shoulder infection over the last 2 weeks since the initial tsa implant.The patient was revised, and an antibiotic spacer was placed.The patient was last known to be in stable condition following the event, devices will not return, facility disposed of them.
Additional Manufacturer Narrative
Section h10: (h3) 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 patient¿s underlying condition.

• Brand Name: EQUINOXE
• Common Device Name: REVERSE 42MM HUMERAL CONST LINER +0
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11751704
• Report Number: 1038671-2021-00207
• Device Sequence Number: 19777681
• Product Code: KWT
• UDI-Device Identifier: 10885862086716
• UDI-Public: 10885862086716
• 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: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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: 06/29/2025
• Device Model Number: 320-42-10
• Device Catalogue Number: 320-42-10
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 07/07/2021
• 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