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	Hematoma (1884)
Date of Event	11/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent a successful reverse shoulder arthroplasty and there were no issues at the first routine clinic visit.At the second visit at six weeks post procedure, the patient reported increased pain and brusing on the shoulder without any trauma.X-rays showed that the implants were stable and ultrasound was performed and the subscapularis tendon appeared to be intact.A ct scan was performed a week later and this did not reveal any bony abnormalities or fractures.Aspiration was attempted and 2cc of serous fluid was removed.An mri revealed a hematoma in deltoid.900 cc was aspirated.A decision was made to perform evacuation of the hematoma and this was conduction approximately two months post procedure along with irrigation and debridement.The patient returned to clinical approximately six weeks after the hematoma evacuation and reported less pain and x-ray showed everything was stable.The physician assigned a possible relationship to the device and procedure.

• 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; grand rapids MI 49507
• Manufacturer Contact: alyson newell ; 1535 steele ave sw; suite b; grand rapids, MI 49507
• MDR Report Key: 24593944
• Report Number: 3012544635-2026-00007
• Device Sequence Number: 18730816
• 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: 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): 03/12/2025

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: 2N2SN06280
• Device Catalogue Number: 2N2SN06280
• Device Lot Number: TJCP06
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BASEPLATE.; GLENOSPHERE.; HUMERAL BEARING.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Female