MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS SPACER 42+6MM; SHOULDR PROSTH, REVERSE CONFIG

Model Number	UNIVERS REVERS SPACER 42+6MM
Medical Device Problem Codes	Positioning Failure (1158); Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/12/2025
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 (b)(6)2025, a sales representative reported via phone that a patient underwent revision surgery.The patient had implants from another manufacturer and those implants were attempted to be paired with an ar-9502f-42cpc arthrex univers revers suture cup and a 9 mm stem.The stem and cup were well fixed while the baseplate and glenoid components from another manufacturer had been levered out.Because the stem was well fixed the surgeon decided to convert it to a ca head to give the patient a minimal amount of movement.The poly was removed, and cup was cleaned then a 42 insert was opened in which the surgeon could not get the ca insert to a couple with the ar-9502f-42cpc arthrex univers revers suture cup.A new ar-9502f-42cpc arthrex univers revers suture cup was opened and was attempted to be inserted again with no avail.A new insert was opened, which physically, it looked different, it was slightly bigger and would not allow to seat into the cup.Finally, a 93 cup of a 39 insert was able to work.This was discovered during a revision revers surgery on (b)(6) 2025.Additional information requested on 2/28/2025.
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 the surgeon's attempt to use our devices in conjunction with components from another manufacturer.

• Brand Name: UNIVERS REVERS SPACER 42+6MM
• Common Device Name: SHOULDR PROSTH, REVERSE CONFIG
• 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: 21606720
• Report Number: 1220246-2025-00943
• Device Sequence Number: 9467146
• Product Code: PHX
• UDI-Device Identifier: 00888867062313
• UDI-Public: (01)00888867062313(11)240201(17)290131(10)23.05005
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K142863
• 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): 09/03/2025

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 SPACER 42+6MM
• Device Catalogue Number: AR-9550-06
• Device Lot Number: 23.05005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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