MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS VAULTLOCK GLENOID, LARGE; PROSTHESIS, SHOULDER, CEMENTED

Model Number	UNIVERS VAULTLOCK GLENOID, LARGE
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/15/2025
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
On 4/15/2025, a clindex notification was received via email indicating that a patient listed in the shoulder arthroplasty registry experienced a subscapularis failure.As a result, the patient underwent a revision procedure, converting to a different type of arthroplasty.The initial eclipse procedure had been performed on (b)(6) 2024.The event was determined to be unrelated to the original surgery.Additional information received on 5/14/2025: during the revision surgery on (b)(6) 2025, an ar-9347-18 arthrex eclipse humeral head, an ar-9301-03 arthrex eclipse cage screw large, an ar-9301-47cpc arthrex eclipse trunion, and an ar-9106-03 arthrex univers vaultlock glenoid were explanted.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed by the study findings presented in the shoulder arthroplasty registry conducted by the regents of the university of michigan regarding implant removal.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 a patient-specific event.Complaint allegation is not confirmed by the study findings presented in the shoulder arthroplasty registry conducted by the regents of the university of michigan regarding implant removal.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 a patient-specific event.

• Brand Name: UNIVERS VAULTLOCK GLENOID, LARGE
• 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: 22162004
• Report Number: 1220246-2025-02417
• Device Sequence Number: 20704011
• Product Code: KWS
• UDI-Device Identifier: 00888867239333
• UDI-Public: (01)00888867239333(11)230601(17)280531(10)S81303073
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K161108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2025

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 VAULTLOCK GLENOID, LARGE
• Device Catalogue Number: AR-9106-03
• Device Lot Number: S81303073
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown