MAUDE Adverse Event Report: SHOULDER INNOVATIONS HUMERAL SHORT STEM

Model Number	2N2SN06280
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	11/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that at a clinic visit approximately six months after a successful total shoulder arthroplasty, the patient reported pain in the anterior aspect of the shoulder consistent with the location of the biceps tenodesis.The surgeon gave the patient a steroid injection into the shoulder and reported that the event was possibly the device and the procedure.No other information was provided.
Additional Manufacturer Narrative
A device history record review could not be conducted as the lot was not provided.Based on the available information, there is no allegation that the device malfunctioned.The surgeon related the event as possibly related to both the procedure and the device, so the most probable cause is known inherent risk of device.

• Brand Name: HUMERAL SHORT STEM
• Common Device Name: HUMERAL SHORT 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; shoulder innovations MI 49507
• Manufacturer Contact: alyson newell ; 1535 steele ave sw; suite b; grand rapids, MI 49507 ; 4086670535
• MDR Report Key: 24607649
• Report Number: 3012544635-2026-00014
• Device Sequence Number: 21290608
• Product Code: MBF
• UDI-Device Identifier: B1132N2SN062800
• UDI-Public: B1132N2SN062800
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K241817
• 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): 03/16/2026

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: 2N2SN06280
• Device Catalogue Number: 2N2SN06280
• 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 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: GLENOID; HUMERAL HEAD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Female