MAUDE Adverse Event Report: SHOULDER INNOVATIONS INSET 95 HUMERAL STEM

Model Number	2L1S040001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	12/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device history record review could not be conducted as the lot number was not provided.Based on the information provided, there was no allegation of a device malfunction.The patient stated that they did not comply with the physical therapy plan, and while the surgeon related the event to the procedure and the device, this is the most likely cause of the reported event.Therefore, the most probable cause is cause traced to non-device related factors.
Event or Problem Description
It was reported that the patient presented at a clinic visit approximately one year after undergoing a successful reverse shoulder arthroplasty procedure, with a complaint of shoulder stiffness and limited range of motion.X-rays showed that there were no issues with the implanted devices.The patient stated that they did not complete the standard of care physicial therapy plan after the surgery.The surgeon decided to inject the shoulder and stated the event could possibly be related to the device and the procedure.No further information was provided.

• Brand Name: INSET 95 HUMERAL STEM
• Common Device Name: INSET 95 HUMERAL STEM
• Manufacturer (Section D): SHOULDER INNOVATIONS; 1535 steele ave sw; suite b; grand rapids MI 49507
• Manufacturer (Section G): SHOULDER INNOVATIONS; 1535 steele ave sw; suite b; grand rapids MI 49507
• Manufacturer Contact: alyson newell ; 1535 steele ave sw; suite b; grand rapids, MI 49507 ; 4086670535
• MDR Report Key: 24605371
• Report Number: 3012544635-2026-00012
• Device Sequence Number: 10343543
• Product Code: MBF
• UDI-Device Identifier: B1132L1S0400010
• UDI-Public: B1132L1S0400010
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K252221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/16/2026

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 Model Number: 2L1S040001
• Device Catalogue Number: 2L1S040001
• 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: 02/24/2026
• Initial Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: BASEPLATE.; GLENOSPHERE.; HUMERAL BEARING.; TRAY.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Female