MAUDE Adverse Event Report: SHOULDER INNOVATIONS INSET 95 HUMERAL STEM

Model Number	2L1S060001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device record review did not find any non-conformances during the manufacture of the device; it met all specifications.There is no allegation of device malfunction, and the device remains implanted so is not available for analysis.The surgeon stated that the fracture occurred while placing the device.Fracture is a known risk associated with the procedure, so the probable cause is known inherent risk of device.
Event or Problem Description
It was reported that during a reverse shoulder arthroplasty, the patient suffered a calcar fracture while placing the humeral stem.The fracture was repaired using cerciage and the proximal calcar tensioned with suturetape.There was no malfunction of the stem but the surgeon did relate the fracture to the device.The suregon will follow up regarding the fracture with x-rays at clinic visits.No other 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: 24610304
• Report Number: 3012544635-2026-00016
• Device Sequence Number: 10224630
• Product Code: MBF
• UDI-Device Identifier: B1132L1S0600010
• UDI-Public: B1132L1S0600010
• 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: 2025
• 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): 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
• Device Model Number: 2L1S060001
• Device Catalogue Number: 2L1S060001
• Device Lot Number: AKB06
• 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
• Date Device Manufactured: 06/20/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female