MAUDE Adverse Event Report: SHOULDER INNOVATIONS HUMERAL SHORT STEM SYSTEM; HUMERAL HEAD

Model Number	2N2HE19050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 23 days post a total shoulder arthroplasty, the patient presented as the first pre-operative visit with a rotator cuff tear that was described as significant by the surgeon and was not present prior to the operation.The patient reportedly had a "choking attack" the night before the visit.The patient underwent surgical intervention.No other information was provided and there was no reported clinical consequence to the patient.

• Brand Name: HUMERAL SHORT STEM SYSTEM
• Common Device Name: HUMERAL HEAD
• 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 rapides, MI 49507 ; 4086670535
• MDR Report Key: 23907140
• Report Number: 3012544635-2025-00006
• Device Sequence Number: 8955295
• Product Code: HSD
• UDI-Device Identifier: B1132N2HE190500
• UDI-Public: B1132N2HE190500
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/29/2025

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: 2N2HE19050
• Device Catalogue Number: 2N2HE19050
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 12/29/2025
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 24MM X 5 DEGREE GLENOID28MM STEMLESS STEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male