MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS SUTURE CUP, 42 (+2 LEFT); SHOULDR PROSTH HEMI- HUM UNCEM

Model Number	UNIVERS REVERS SUTURE CUP, 42 (+2 LEFT)
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 04/23/2024, it was reported by a sales representative via email that an ar-9502f-42lcpc arthrex univers revers suture cup would not screw into the stem.A new suturecup was used to complete the case.This was discovered during a procedure on (b)(6) 2024.Additional information received on 4/26/2024: ar-9502f-42lcpc arthrex univers revers suture cup would not screw into an ar-9501-12s univers revers apex humeral stem.A new ar-9502f-42lcpc arthrex univers revers suture cup was used to complete the case.This was discovered during a revers total shoulder procedure.The case was not delayed.Additional anesthesia was unnecessary, and the patient suffered no negative effects.
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 use error due to improper humeral stem assembly.

• Brand Name: UNIVERS REVERS SUTURE CUP, 42 (+2 LEFT)
• 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: 19359113
• Report Number: 1220246-2024-03574
• Device Sequence Number: 17075729
• Product Code: HSD
• UDI-Device Identifier: 00888867234260
• UDI-Public: 00888867234260
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161782
• 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): 05/21/2025

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 SUTURE CUP, 42 (+2 LEFT)
• Device Catalogue Number: AR-9502F-42LCPC
• Device Lot Number: 22.04723
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2023
• 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