MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS SUTURE CUP, 33 (+2 LEFT); SHOULDR PROSTH, REVERSE CONFIG

Model Number	UNIVERS REVERS SUTURE CUP, 33 (+2 LEFT)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	03/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 7/18/2024, a clindex notification was received indicating that a patient listed on the shoulder arthroplasty registry suffered bone fractures in the target shoulder.This event was indicated as possibly related to the univers revers devices implanted on (b)(6) 2024.On (b)(6) 2024, the patient started to experience pain.It was suspected the patient suffered an acromial fracture, which was confirmed in april via ct scan.The patient was immobilized in a sling for six weeks.On (b)(6) 2024, the patient reported no pain; x-ray images revealed a healed fracture.The patient did not suffer a fall or have an injury.The pain began after physical therapy.The implants are not loose or broken.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause is a patient-specific event.

• Brand Name: UNIVERS REVERS SUTURE CUP, 33 (+2 LEFT)
• Common Device Name: SHOULDR PROSTH, REVERSE CONFIG
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19941658
• Report Number: 1220246-2024-07109
• Device Sequence Number: 15292204
• Product Code: HSD
• UDI-Device Identifier: 00888867406896
• UDI-Public: 00888867406896
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K221232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

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: UNIVERS REVERS SUTURE CUP, 33 (+2 LEFT)
• Device Catalogue Number: AR-9502F-33LCPC
• Device Lot Number: 22.00590
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2024
• Supplement Date Received by Manufacturer: 06/08/2025
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown