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 Joint Dislocation (2374)

Event Date 02/21/2024

Event Type  Injury  

Manufacturer Narrative

Section d10: concomitant products - equinoxe reverse tray adapter plate tray +5 (cat# 320-10-05 / serial# (b)(6) ).- eq reverse torque defining screw kit (cat# 320-20-00 / serial# (b)(6) ).- equinoxe reverse 42mm humeral liner +0 (cat# 320-42-00 / serial# (b)(6) ).- eq rev locking screw (cat# 320-15-05 / serial# (b)(6) ).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported, approximately 1.5 years post initial right tsa, the 60 y/o male patient was revised due to dislocation.The patient was revised to a 42mm, +4mm expanded glenosphere and a 42mm liner.The torque screw kit, adapter tray and locking screw were also revised.There was no breakage of device or surgical delay/prolongation patient was last known to be in stable condition following the event.The sales rep was unable to obtain photos/x-rays.The devices are not available for evaluation due to hospital did not return.No other patient information/medical history reported.

• 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: michael crader
• MDR Report Key: 18946343
• MDR Text Key: 338186311
• Report Number: 1038671-2024-00596
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086402
• UDI-Public: 10885862086402
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• 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: 02/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/20/2018
• 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
• Treatment: EQUINOXE HUMERAL LONG STEM 10MM 200MM.; RS GLENOID PLATE POST AUG, 8 DEG, RIGHT.
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male