MAUDE Adverse Event Report: SHOULDER INNOVATIONS INSET 95 HUMERAL STEM

Model Number	2L1S080001
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Approximately 1 month after shoulder arthroplasty, th patient reported in the week leading up to a routine clinic visit, feeling a sharp pain and shift in the surgical shoulder while sitting in a chair.An x-ray taken at the clinic visit showed an abnormality that the surgeon determined was implant loosening on the humeral side.The patient underwent revision surgery to address the issue with no reported clinical consequence.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: 24549344
• Report Number: 3012544635-2026-00005
• Device Sequence Number: 12184636
• Product Code: MBF
• UDI-Device Identifier: B1132L1S0800010
• UDI-Public: B1132L1S0800010
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K241817
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted 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): 02/11/2026

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?: Yes
• Operator of Device: Health Professional
• 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: 02/11/2026
• Initial Report FDA Received Date: 03/09/2026
• 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: Required Intervention
• Patient Sex: Male