MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS HUMERAL STEM, 5MM; SHOULDR PROSTH HEMI- HUM UNCEM

Model Number	UNIVERS REVERS HUMERAL STEM, 5MM
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
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)2024, it was reported by a sales representative via email that a 33 mm suturecup screw would not tighten to an ar-9501-05p univers revers humeral stem.The surgeon used the stem assembly block and the up/stem adapter when the issue was first noticed.After several attempts to get the screw seated, the surgeon removed the adapter from the suturecup to confirm that everything was seated correctly.The surgeon noted that the screw would advance slightly but then would hit a hard stop and wouldn't advance further.After several failed attempts and to avoid stripping the suturecup screw, a new stem was opened and assembled to the cup with no issues, and the case continued as normal.This was discovered during an rts procedure on (b)(6)2024.
Additional Manufacturer Narrative
Correction: h1 to n/a.Arthrex previously submitted this event as a reportable malfunction out of an abundance of caution.Upon receiving additional information from the field that clarified the event, it has been determined that this event does not meet the criteria of a reportable event under 21 cfr 803.Additional information: b5, h3, h6.
Event or Problem Description
Additional information received on 1/13/2025: the part number for the univers revers suturecup 33 used with the new humeral stem is ar-9502f-33cpc.This issue occurred when the implants were being assembled together on the back table before any of the implants touched the patient.The case was no delayed in the case and additional anesthesia was not needed.
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 of the device due to applying excessive mechanical forces during use and/or misaligned insertion.

• Brand Name: UNIVERS REVERS HUMERAL STEM, 5MM
• 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: 21190871
• Report Number: 1220246-2025-00015
• Device Sequence Number: 12921594
• Product Code: HSD
• UDI-Device Identifier: 00888867247628
• UDI-Public: (01)00888867247628(11)240101(17)281231(10)23.02161
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 09/15/2025

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 REVERS HUMERAL STEM, 5MM
• Device Catalogue Number: AR-9501-05P
• Device Lot Number: 23.02161
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2024
• Supplement Date Received by Manufacturer: Not provided; 09/09/2025
• Initial Report FDA Received Date: 01/20/2025
• Supplement Report FDA Received Date: 02/05/2025; 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown