MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 40MM HUM LINER +0; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	320-40-00
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 10 months after initial right tsa, the patient was revised after feeling pain while doing handy work.The glenosphere was loose and was replaced along with a new poly liner and screw.The event is related to the breakage of a device.All pieces that fell into the wound site were removed.The event did not lead to a surgical delay/prolongation.
Additional Manufacturer Narrative
Concomitants: (b)(6); 300-30-11 - equinoxe preserve stem 11mm.(b)(6); 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6); 320-20-00 - eq reverse torque defining screw kit.(b)(6); 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm.(b)(6); 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.(b)(6); 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6); 320-35-01 - small glenoid plate.(b)(6); 320-40-00 - 145-deg pe 40mm hum liner +0.(b)(6); 321-20-00 - equinoxe reverse shoulder drill kit.(b)(6); 321-52-10 - 3.2mm k-wire, thd, short 2 k-wires per pack.(b)(6); 320-32-40 - expanded glenosphere, 40mm, for small reverse.The revision reported was likely the result of disassembly of the glenosphere locking screw from the glenoid baseplate.The deformation observed on the explanted locking screw could have resulted from abnormal articulation as the screw backed out over time or incomplete seating at the time of implantation.A secondary finding of prosthesis wear likely resulted from abnormal articulation between the liner and glenoid baseplate following the locking screw disassembly.However, the series of events cannot be confirmed from the information provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: 145-DEG PE 40MM HUM LINER +0
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 23335132
• Report Number: 1038671-2025-03145
• Device Sequence Number: 21293405
• Product Code: PHX
• UDI-Device Identifier: 10885862535030
• UDI-Public: 10885862535030
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/20/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 320-40-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male