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

Model Number	2R1GLC0633
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	12/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a successful reverse shoulder arthroplasty and at the follow up clinic visit two weeks later, the patient complained of increased pain in the superior aspect of the shoulder.X-rays showed a non-displaced scapular spine fracture that the surgeon stated was a fatigue type fracture.The patient was instructed to stop physical therapy.The patient returned at the next clinic follow up visit, approximately six weeks post procedure and was diagnosed with no union of the fracture and an exogen bone stimulator was ordered.The surgeon state the event was possibly related to the device and the procedure, there was no allegation of any device malfunction.No further information was provided.
Additional Manufacturer Narrative
A device history record review did not identify any nonconformances or deviations during the manufacture of the device; the device met all specifications.The device remains implanted and was not returned for analysis, and the surgeon did not allege any malfunction of the device had occurred.Based on the information available, this event is a known inherent risk of the device.

• 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: 24605078
• Report Number: 3012544635-2026-00011
• Device Sequence Number: 10350775
• Product Code: PHX
• UDI-Device Identifier: B1132R1GLC06330
• UDI-Public: B1132R1GLC06330
• 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: 2R1GLC0633
• Device Catalogue Number: 2R1GLC0633
• Device Lot Number: UIECO3
• 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
• Date Device Manufactured: 11/30/2023
• 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 BEARING; HUMERAL SHORT STEM; HUMERAL TRAY
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female