MAUDE Adverse Event Report: SHOULDER INNOVATIONS INSET REVERSE TOTAL SHOULDER; RSA CONSTRAINED HUMERAL BEARING

Model Number	2R1P150533
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had "advanced osteoarthritis" and was to undergo a reverse total shoulder arthroplasty.When accessing the shoulder it was found that the patient had a highly attenuated subscapularis in a very diseased biceps tendon.The subscapularis was carefully removed from the lower tuberosity and the proximal humerus exposed and examined.Periperal osteophytes were removed.Following osteotomy, gross osteoporosis and poor bone quality were noted.A roximal humeral protector was "gently" put on the proximal humerus and then relocated in the wound and retracted posteriorly.However, as soon as the surgeon retracted, there was a fracture of both the greater and lesser tuberosities.Patient was treated with cerclage sutures around the proximal humerus during surgery.The surgeon did not relate the fractures to the device but did relate it to the surgical procedure.Due to the complexities of the case and the patient's poor bone quality the patient was under anesthesia for an additional period.There was no other clincial consequence to the patient.

• Brand Name: INSET REVERSE TOTAL SHOULDER
• Common Device Name: RSA CONSTRAINED HUMERAL BEARING
• 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: 25435403
• Report Number: 3012544635-2026-00023
• Device Sequence Number: 10284607
• Product Code: PHX
• UDI-Device Identifier: B1132R1P1505330
• UDI-Public: B1132R1P1505330
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K254128
• 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): 06/08/2026

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: 2R1P150533
• Device Catalogue Number: 2R1P150533
• Device Lot Number: UJCAA2
• 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: 05/20/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2024
• 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 TRAY; INSET FXR 135; OFFSET GLENOSPHERE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female