MAUDE Adverse Event Report: SHOULDER INNOVATIONS INSET REVERSE TOTAL SHOULDER; OFFSET GLENOSPHERE

Model Number	2R1GLC0333
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	11/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device history record review could not be performed as the lot number was not reported.There is no allegation that the device malfunctioned, x-rays showed that the shoulder was "normal" and there was nothing remarkable relating to the implants.The surgeon did state that the event was possibly related to the procedure or the device, therefore the most likely cause is known inherent risk of device.
Event or Problem Description
It was reported that approximately six months after a successful reverse shoulder arthroplasty, the patient reported shoulder stiffness at the scheduled clinic visit.X-rays showed that the shoulder "looked normal".The surgeon decided to give the patient an injection into the shoulder and possibly related the event to the procedure and the device.No other information was provided.

• Brand Name: INSET REVERSE TOTAL SHOULDER
• Common Device Name: OFFSET GLENOSPHERE
• 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: 24607263
• Report Number: 3012544635-2026-00013
• Device Sequence Number: 15709899
• Product Code: PHX
• UDI-Device Identifier: B1132R1GLC03330
• UDI-Public: B1132R1GLC03330
• 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): 03/16/2026

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
• Operator of Device: Health Professional
• Device Model Number: 2R1GLC0333
• Device Catalogue Number: 2R1GLC0333
• 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: BASEPLATE.; HUMERAL BEARING.; HUMERAL SHORT STEM.; TRAY.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Female