MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS APEX OPTIFIT HUMERAL STEM, 6MM; PROSTHESIS, SHOULDER, CEMENTED

Model Number	UNIVERS APEX OPTIFIT HUMERAL STEM, 6MM
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
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) 2026, a sales representative reported via email that an ar-9100-06m univers apex optifit humeral stem, 6 mm, had an inferior locking screw that would not fully lock the device.The case was completed by removing the implant device from the patient and up-sizing to an ar-9100-09m univers apex optifit humeral stem, 9mm, without issues.The case was delayed 20-25 minutes, and it is uncertain whether additional anesthesia was administered.This was discovered during a total shoulder arthroplasty procedure on (b)(6) 2026, with no reported patient harm.

• Brand Name: UNIVERS APEX OPTIFIT HUMERAL STEM, 6MM
• Common Device Name: PROSTHESIS, SHOULDER, CEMENTED
• 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: 24638447
• Report Number: 1220246-2026-01514
• Device Sequence Number: 18602533
• Product Code: HSD
• UDI-Device Identifier: 00888867404274
• UDI-Public: (01)00888867404274(11)250708(17)300630(10)15462612
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K230513
• 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): 07/08/2026

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 APEX OPTIFIT HUMERAL STEM, 6MM
• Device Catalogue Number: AR-9100-06M
• Device Lot Number: 15462612
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/27/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown