MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE PRESERVE STEM 8MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	300-30-08
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Periprosthetic fracture (4902)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0, (b)(6), 320-31-40 - glenosphere, 40mm, (b)(6), 320-35-06 - small extended cage glenoid plate, (b)(6), 320-40-03 - 145-deg pe 40mm hum liner +2.5.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.This cause of the reported event is most likely patient conditions, however; cannot be confirmed as the device was not available for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported via clinical study that a reverse total shoulder arthroplasty.Subsequently, approximately three (3) months later, on an unknown date, the patient had a fracture in the proximal humerus region in the absence of trauma.The surgeon noted it is extremely unusual following reverse total shoulder arthroplasty but may reflect too great active use or too aggressive physical therapy.Medication was prescribed and the patient was advised to stop supervised physical therapy for the next six (6) weeks, as well as any overhead stretching exercises.The patient was instructed to do pendulum exercises for six (6) weeks and then return to the surgeon for repeat evaluation and radiographs.The patient's outcome was reported as resolved on follow up visit eleven (11) months post initial surgery.No additional information is available.

• Brand Name: EQUINOXE PRESERVE STEM 8MM
• 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 32653
• Manufacturer Contact: katy priest ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 25234470
• Report Number: 1038671-2026-00638
• Device Sequence Number: 10356894
• Product Code: PHX
• UDI-Device Identifier: 10885862515766
• UDI-Public: 10885862515766
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K162726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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: 300-30-08
• 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: 02/03/2023
• Initial Report FDA Received Date: 05/20/2026
• Date Device Manufactured: 03/15/2021
• 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: Other
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White