MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 38MM GLENOSPHERE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-01-38

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

Patient Problem Failure of Implant (1924)

Event Date 11/27/2023

Event Type  Injury  

Event Description

As reported, the patient had an initial left tsa on (b)(6) 2021.The patient was revised on (b)(6) 2023 due to instability.The humeral liner, glenosphere, screw kit and locking screw were revised.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.

Manufacturer Narrative

H3: pending investigation.D10: 6649871 - 300-01-13 - equinoxe, humeral stem primary, press fit 13mm 6762017 - 315-35-00 - glnd kwire 6783722 - 320-01-38 - equinoxe reverse 38mm glenosphere 6669113 - 320-10-00 - equinoxe reverse tray adapter plate tray +0 6689487 - 320-15-01 - eq rev glenoid plate 6732015 - 320-15-05 - eq rev locking screw 6807775 - 320-20-00 - eq reverse torque defining screw kit s129729 - 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm s124391 - 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm s200159 - 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm s110707 - 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm s210915 - 320-38-00 - equinoxe reverse 38mm humeral liner +0 6801245 - 321-20-00 - equinoxe reverse shoulder drill kit.

• Brand Name: EQUINOXE REVERSE 38MM 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18345545
• MDR Text Key: 330727982
• Report Number: 1038671-2023-03005
• Device Sequence Number: 1
• Product Code: KWT
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-01-38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/16/2020
• 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
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Sex: Male