MAUDE Adverse Event Report: EXACTECH, INC. SMALL POSTERIOR AUGMENT GLENOID PLATE, LEFT; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	320-35-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the equinoxe shoulder study, approximately 0 year(s) and 3 month(s) post-operative of a left implanted tsa, the patient presented with unexplained pain.It was reported the patient experienced pain lifting a gallon of milk.This outcome of the event is reported to be resolved with no actions taken.The clinical report indicates that the event is unlikely related to the device(s) and/or to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.
Additional Manufacturer Narrative
(d10) concomitant device(s): 300-30-07 - equinoxe preserve stem 7mm.320-10-00 - equinoxe reverse tray adapter plate tray +0.320-31-36 - glenosphere, 36mm.320-36-00 - 36mm humeral liner +0 unconstrained.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the pain reported cannot be conclusively determined but may be related to an underlying patient condition.However, this cannot be confirmed because the devices were not returned for evaluation, and relevant patient information, images, or radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: SMALL POSTERIOR AUGMENT GLENOID PLATE, LEFT
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct; gainesville FL
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19570423
• Report Number: 1038671-2024-02009
• Device Sequence Number: 12503420
• Product Code: PHX
• UDI-Device Identifier: 10885862534880
• UDI-Public: 10885862534880
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 320-35-03
• 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: 05/29/2024
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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.
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White