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

Model Number	2R1GLC0636
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	02/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a successful reverse shoulder arthroplasty and there were no issues noted at the first clinic visit two weeks post procedure.At the second clinic visit, approximately six weeks post procedure, the patient was found to have capsulitis with range of motion scores reduced from the pre-opertative evaluation.Medical intervention was performed, the details were not provided.The surgeon did not related the event to the device and there was no allegation that the implant had malfunctioned.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: 24604671
• Report Number: 3042544635-2026-00010
• Device Sequence Number: 15677274
• Product Code: PHX
• UDI-Device Identifier: B1132R1GLC06360
• UDI-Public: B1132R1GLC06360
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K252221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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: 2R1GLC0636
• Device Catalogue Number: 2R1GLC0636
• 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: 02/23/2026
• 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.; INSET PRIMARY LONG STEM.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Male