MAUDE Adverse Event Report: EXACTECH, INC. SUP/POST AUG PLATE, R RS GLENOID BASEPLATE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	SUP/POST AUG PLATE, R RS GLENOID BASEPLATE
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	07/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: serial number; item number and full description; (b)(6) 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6) 320-42-00 - equinoxe reverse 42mm humeral liner +0.(b)(6) 300-30-06 - equinoxe preserve stem 6mm.(b)(6) 320-06-42 - glenosphere 42mm.
Event or Problem Description
As reported by the exactech equinoxe shoulder study, the patient had an initial right tsa on (b)(6) 2020.The patient presented on (b)(6) 2022 with aseptic glenoid loosening and was revised to non-exactech devices on (b)(6) 2022.The case report form indicates this event is definitely related to the device and procedure.This event report was received through clinical data collection activities.Outcome: resolution date: (b)(6) 2022.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported may be the result of the glenoid loosening as reported.However, the loosening cannot be confirmed and any potential contributions from manufacturing, user, or patient-related contributing factors to the event cannot be evaluated as no radiograph, images, or clinical information was provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: SUP/POST AUG PLATE, R RS GLENOID BASEPLATE
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-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: 17711136
• Report Number: 1038671-2023-02200
• Device Sequence Number: 16681645
• Product Code: KWS
• UDI-Device Identifier: 10885862242563
• UDI-Public: 10885862242563
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K131575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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?: No
• Device Model Number: SUP/POST AUG PLATE, R RS GLENOID BASEPLATE
• Device Catalogue Number: 320-15-08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2023
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2019
• 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 H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown