MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 46MM GLENOSPHERE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number EQUINOXE REVERSE 46MM GLENOSPHERE

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

Patient Problem Unspecified Infection (1930)

Event Date 03/11/2024

Event Type  Injury  

Manufacturer Narrative

Section d10: concomitant devices: equinoxe preserve stem 10mm (cat# 320-30-10 / serial# (b)(6)) glnd kwire (cat# 315-35-00 / serial# (b)(6)) equinoxe reverse tray adapter plate tray +0 (cat# 320-10-00 / serial# (b)(6)) eq rev glenoid plate (cat# 320-15-01 / serial# (b)(6)) eq rev locking screw (cat# 320-15-05 / serial# (b)(6)) eq reverse torque defining screw kit (cat# 320-20-00 / serial# (b)(6)) eq rev compress screw lck cap kit, 4.5 x 18mm (cat# 320-20-18 / serial# (b)(6)) eq rev compress screw lck cap kit, 4.5 x 22mm (cat# 320-20-22 / serial# (b)(6) ) eq rev compress screw lck cap kit, 4.5 x 22mm (cat# 320-20-22 / serial# (b)(6) ) equinoxe reverse 46mm humeral liner +0 (cat# 320-46-00 / serial# (b)(6) ) equinoxe reverse shoulder drill kit (cat# 321-20-00 / serial# (b)(6)) additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

It was reported that an 80 yo male patient, initial shoulder implanted on (b)(6) 2017, underwent a revision procedure on (b)(6) 2024, approximately 6 years 10 months post the initial procedure.The patient was revised due to issues since their primary surgery, could be infection, but the surgeon wants to make a report just in case.The surgeon suspects possible poly wear.There were no device breakages or surgical delays during the procedure.No x-rays were provided.The patient was last known to be in stable condition following the event.No explanted devices are available for analysis as they were sent to pathology at the hospital.Device images were provided.No further information.

• Brand Name: EQUINOXE REVERSE 46MM GLENOSPHERE
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: matt collins
• MDR Report Key: 19121871
• MDR Text Key: 340338187
• Report Number: 1038671-2024-00866
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086402
• UDI-Public: 10885862086402
• Combination Product (y/n): N
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EQUINOXE REVERSE 46MM GLENOSPHERE
• Device Catalogue Number: 320-01-46
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/13/2017
• 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): Required Intervention
• Patient Sex: Male