MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS HUMERAL STEM, SIZE 7; SHOULDR PROSTH HEMI- HUM UNCEM

Model Number	UNIVERS REVERS HUMERAL STEM, SIZE 7
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/16/2023
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 (b)(6) 2024, it was reported by a sales representative via email that an ar-9564-2442-lat glenosphere and glenosphere set screw disengaged from the baseplate.The patient underwent surgery on (b)(6) 2023 for a reverse shoulder arthroplasty.Postoperatively the patient experienced pain and a ct scan revealed glenosphere and glenosphere set screw disengaged from the baseplate.On (b)(6) 2023 the patient underwent a revision surgery in which a new glenosphere along with humeral components were implanted.No further information was provided.Additional information received on 11/4/2024: during the revision surgery, the ar-9502f-39lcpc suturecup, the ar-9503-3942-3 humeral insert, the ar-9501-07p humeral stem, the ar-9582-20 modular post, the ar-9563-28 peripheral locking screw, the ar-9563-16 peripheral locking screw, the ar-9563-20 peripheral locking screw, the ar-9562-40nl peripheral locking screw, the ar-9580-2010-2s baseplate, and ar-9564-2442-lat glenosphere was removed.Both procedures were performed by the same surgeon and at the same facility.
Additional Manufacturer Narrative
Correction: b3.

• Brand Name: UNIVERS REVERS HUMERAL STEM, SIZE 7
• Common Device Name: SHOULDR PROSTH HEMI- HUM UNCEM
• 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: 20726273
• Report Number: 1220246-2024-08558
• Device Sequence Number: 12860935
• Product Code: HSD
• UDI-Device Identifier: 00888867250390
• UDI-Public: (01)00888867250390(11)210901(17)260831(10)21.02467
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K161782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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 Expiration Date: 08/31/2026
• Device Model Number: UNIVERS REVERS HUMERAL STEM, SIZE 7
• Device Catalogue Number: AR-9501-07P
• Device Lot Number: 21.02467
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2021
• 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