MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS APEX OPTIFIT HUMERAL STEM, 10MM; PROSTHESIS, SHOULDER, CEMENTED

Model Number	UNIVERS APEX OPTIFIT HUMERAL STEM, 10MM
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
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 08/08/2025, it was reported by a sales representative via (b)(4) that an ar-9100-10m humeral stem inferior screw would not turn.This occurred during use in a case with no patient effect.The issue was identified intraoperatively while the patient was on the table.This created an immediate need for resolution to proceed with the surgery without delay.The attending surgeon manipulated the screw mechanism and was ultimately able to get it to function, allowing the procedure to continue.The screw was noted to be difficult to operate initially, which could indicate a potential manufacturing or presetting issue.
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 for the reported failure can be attributed to user error due to misaligned insertion and/or improper bone preparation.Dfu-0131-eo: the following operative situations may cause premature loosening and complications: extreme weakening of the bone structure in preparing the bone bed.The complaint allegation could not be confirmed as the device was not received for investigation.

• Brand Name: UNIVERS APEX OPTIFIT HUMERAL STEM, 10MM
• 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: 22885326
• Report Number: 1220246-2025-03625
• Device Sequence Number: 4915491
• Product Code: HSD
• UDI-Device Identifier: 00888867404311
• UDI-Public: 00888867404311
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K230513
• 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): 12/15/2025

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 APEX OPTIFIT HUMERAL STEM, 10MM
• Device Catalogue Number: AR-9100-10M
• Device Lot Number: 15359047
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown