MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS HUMERAL STEM, SIZE 10; SHOULDR PROSTH HEMI- HUM UNCEM

Model Number	UNIVERS REVERS HUMERAL STEM, SIZE 10
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by a sales representative via (b)(4) that a 36 univers revers ca humeral head adapter and a ca humeral head disengaged from an ar-9502f-39cpc arthrex univers revers suturecup and humeral stem.Then, the 36 univers revers ca humeral head adapter and the ca humeral head could not be taken apart.Sizing was thought to be an issue, so the surgeon attempted to engage a 39 suturecup and an ar-9502-39arca 39 humeral head adapter on the back table, but they kept coming apart.The case was completed using a 36 humeral head adapter.This was discovered during an rtsa procedure on (b)(6) 2025.This issue added an additional hour and a half to the case which already needed a time limit due to the patient's health and was at a higher risk for surgery.At this time, it is unknown if additional anesthesia was administered.Additional information was received on 3/31/2025: the sales representative provided the part number ar-9501-10p for the arthrex univers revers humeral stem, ar-9550-19rca for the arthrex univers revers ca humeral head, and ar-9556-22rca univers revers ca humeral head.The ar-9501-10p for the arthrex univers revers humeral stem was not exchanged and was the same to complete the case.Additional anesthesia, more than what the anesthesiologist had allowed initially, was administer to the patient due to the hour and a half case delay.The patient is doing well postoperatively, however, has not started range of motion.Additional information requested on 4/14/2025.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.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 attributed to user error due to the wrong insertion/engagement of the device.

• Brand Name: UNIVERS REVERS HUMERAL STEM, SIZE 10
• 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: 21861130
• Report Number: 1220246-2025-01520
• Device Sequence Number: 4695895
• Product Code: HSD
• UDI-Device Identifier: 00888867250420
• UDI-Public: 00888867250420
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: UNIVERS REVERS HUMERAL STEM, SIZE 10
• Device Catalogue Number: AR-9501-10P
• Device Lot Number: 23.05466
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown