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

Model Number	2R1GLC0639
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	01/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that eight days following a reverse shoulder arthroplasty procedure, the patient was hospitalized for a pulmonary embolism.The surgeon did not relate this event to the implanted devices or the surgical procedure.The event was reported as resolved eight days later.No other information was provided.
Event or Problem Description
It was reported that eight days following a reverse shoulder arthroplasty procedure, the patient was hospitalized for a pulmonary embolism.The surgeon did not relate this event to the implanted devices or the surgical procedure.The event was reported as resolved eight days later.No other information was provided.
Additional Manufacturer Narrative
A device history record review could not be conducted as the lot number was not reported and the device remains implanted.Based on all available information, the patient suffered a post procedure pulmonary embolism that the surgeon did not related to the device or procedure.There is no information to suggest that the event was caused or related to the device or the procedure.The cause of the pulmonary emoblism cannot be determined, therefore the probable cause is adverse event unrelated to device or procedure.

• Brand Name: INSET REVERSE TOTAL SHOULDER GLENOSPHERE
• 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: 24551516
• Report Number: 3012544635-2026-00006
• Device Sequence Number: 5662278
• Product Code: PHX
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K241817
• 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,Followup
• Report Date (Section B): 05/15/2026

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: 2R1GLC0639
• Device Catalogue Number: 2R1GLC0639
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 05/15/2026
• 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; INSET PRIMARY LONG STEM; POLYLINER; TRAY
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Male