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	Post Operative Wound Infection (2446)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient initially underwent a total shoulder arthroplasty.Approximately seven months post surgery, the patient underwent a conversion to a reverse total shoulder arthroplasty.The reason for the conversion was not provided.Approximately one month after the conversion, the patient had a revision surgery due to infection.There procedure was successful.It was stated that the patient had many comorbidities but no further information regarding these was provided.It was also stated tha that the patient was "sick" prior to the revision surgery.No further information was provided.
Additional Manufacturer Narrative
A device history record review did not identify any nonconformance that could be related to the reported event and the sterile release record shows that there was no issue with the device sterilization.The device was not returned for analysis so physical investigation could not be performed.Based on the available information, there is no allegation that the reported event was related to the device.The patient had a number of unspecified comorbidities and these could have been a factor in the event but it is unknown as details were not reported.Infection is a known potential risk associated with the procedure and including in the instructions for use, therefore the most probable cause is known inherent risk of device.

• Brand Name: INSET REVERSE TOTAL SHOULDER OFFSET 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: 24193373
• Report Number: 3012544635-2026-00004
• Device Sequence Number: 9649667
• Product Code: PHX
• UDI-Device Identifier: B1132R1GLC03330
• UDI-Public: B1132R1GLC03330
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K25221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/27/2026

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
• Device Lot Number: UKCAA7
• 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: 12/31/2025
• Initial Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2025
• 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 TRAY; NEUTROAL HUMERAL BEARING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female