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

Model Number	UNIVERS II HUMERAL STEM 10MM
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 29-jan-2026, it was reported by a sales representative via phone that an ar-9100-10p humeral stem inserter screw would not advance into the stem and became stuck.This occurred during use in a case with no patient effect.Delay in case 15 minutes.Case was completed using size 11 stem.
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 the complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The port failure is most likely due to user error, specifically the overtightening of the inclination screw, which renders the device inoperative.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: UNIVERS II HUMERAL STEM 10MM
• 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: 24363673
• Report Number: 1220246-2026-00630
• Device Sequence Number: 9660652
• Product Code: KWS
• UDI-Device Identifier: 00888867057128
• UDI-Public: (01)00888867057128(11)240301(17)290228(10)23.05248
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K071032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2026

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 II HUMERAL STEM 10MM
• Device Catalogue Number: AR-9100-10P
• Device Lot Number: 23.05248
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown