MAUDE Adverse Event Report: SHOULDER INNOVATIONS TOTAL SHOULDER ARTHROPLASTY; GLENOID

Model Number	0S0CI24006
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	12/03/2025
Type of Reportable Event	Serious Injury
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, and x-rays did not reveal anything of concern.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.
Event or Problem Description
It was reported that at the clinic visit approximately six months post procedure, the patient reported stiffness of the posterior capsule with intermittent pain.X-rays showed the shoulder was stable.The surgeon decided to give a steroid injection into the shoulder.The surgeon stated that the event was possibly related to the device and the procedure.No other information was provided.

• Brand Name: TOTAL SHOULDER ARTHROPLASTY
• Common Device Name: GLENOID
• 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: 24608178
• Report Number: 3012544635-2020-00015
• Device Sequence Number: 15986952
• Product Code: HSD
• UDI-Device Identifier: B1130S0CI240060
• UDI-Public: B1130S0CI240060
• 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: 0S0CI24006
• Device Catalogue Number: 0S0CI24006
• 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: HUMERAL HEAD; HUMERAL SHORT STEM
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Male