MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS APEX OPTIFIT HUMERAL STEM, 9MM; PROSTHESIS, SHOULDER, CEMENTED

Model Number	UNIVERS APEX OPTIFIT HUMERAL STEM, 9MM
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
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 04/02/2025, a sales representative reported via phone that an ar-9100-09m univers¿ apex optifit humeral stem would not allow the interior screw to engage.This occurred during a total shoulder replacement case on (b)(6) 2025 when they went to insert the 2 screws in the stem and the interior screw would not engage.The case continued by going up a size in the stem and there were no further issues.There was no delay in the procedure.There was no harm to the patient.
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 likely due to using the incorrect size stem.

• Brand Name: UNIVERS APEX OPTIFIT HUMERAL STEM, 9MM
• 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: 21902822
• Report Number: 1220246-2025-01712
• Device Sequence Number: 8623416
• Product Code: HSD
• UDI-Device Identifier: 00888867404304
• UDI-Public: (01)00888867404304(11)240401(17)290331(10)15227783
• 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): 09/22/2025

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, 9MM
• Device Catalogue Number: AR-9100-09M
• Device Lot Number: 15227783
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/02/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown