MAUDE Adverse Event Report: SHOULDER INNOVATIONS INSET 95 HUMERAL STEM

Model Number	2L1S080001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the shoulder arthroplasty procedure, while retracting the surgeon heard a "small crack" and it was noted that the greater tuberosity was fractured.The fracutre did not extend into the calcar or distally.The greater tuberosity fragment was removed and the patient was to be monitored at clinic visits using x-rays.The surgeon did not relate the event to the device but to the procedure.There was no reported clinical consequence to the patient.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: 24595850
• Report Number: 3012544635-2026-00009
• Device Sequence Number: 8689043
• Product Code: MBF
• UDI-Device Identifier: B1132L1S0800010
• UDI-Public: B1132L1S0800010
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 2L1S080001
• Device Catalogue Number: 2L1S080001
• 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: 02/12/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Age: 83 YR
• Patient Sex: Female