MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS GLENO 36 +4 LAT; SHOULDR PROSTH, REVERSE CONFIG

Model Number	UNIVERS REVERS GLENO 36 +4 LAT
Medical Device Problem Codes	Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	07/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that the device dislocated after the surgery.The revision surgery was performed on (b)(6) 2024.The surgeon changed the glenosphere.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-9504s-04 arthrex univers revers¿ glenosphere 36 +4 lat serial/batch number (b)(6) was received for investigation.Functional testing with a known good part found that the glenosphere firmly attached to the mating part.Visual evaluation found scratches and marks on the polished area, most likely caused by the implantation and removal of the device.No other damage was noted.The most likely cause of the reported failure is a patient-specific event, specifically a revision surgery due to dislocation.

• Brand Name: UNIVERS REVERS GLENO 36 +4 LAT
• 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: 20733694
• Report Number: 1220246-2024-08571
• Device Sequence Number: 8370129
• Product Code: PHX
• UDI-Device Identifier: 00888867061408
• UDI-Public: (01)00888867061408(11)230201(17)280131(10)22.02201
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: UNIVERS REVERS GLENO 36 +4 LAT
• Device Catalogue Number: AR-9504S-04
• Device Lot Number: 22.02201
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown