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

Model Number	UNIVERS VAULTLOCK GLENOID, SMALL
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Erosion (1750); Insufficient Information (4580)
Date of Event	03/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On 04-mar-2026, a sales representative reported via email that a patient underwent a revision from eclipse + vaultlock tsa to rtsa on (b)(6) 2026.The patient¿s original surgery date was on (b)(6) 2024.The revision was performed due to subscapularis failure and not due to failure of the eclipse or vaultlock implants.However, significant vaultlock erosion was noted at less than two years post-implantation.The arthrex implants explanted during the revision included: ar-9106-01 arthrex univers vaultlock glenoid, small, ar-9301-02 arthrex eclipse cage screw medium (35.0 mm), ar-9301-39cpc arthrex eclipse trunion 39 mm, slotted, tps cap, and an ar-9339-18 arthrex eclipse humeral head, 39/18.Additional information was received on 10-mar-2026: the patient was initially treated on (b)(6) 2024 for a subscapularis tear sustained during a physical altercation.During the revision, anterior erosion measuring approximately 2¿3 mm was observed.The surgeon did not comment on whether the erosion contributed to the need for revision or if it was an incidental finding.The revision procedure was completed successfully with no case delay and no additional anesthesia reported.No further surgeries are anticipated.The patient was described as stable immediately following the revision procedure; postoperative status beyond leaving the room is unknown.Additional information was received on 16-mar-2026: the arthrex implant ar-9400-sbk eclipse speedscap implant system was explanted during the revision.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
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 a patient-specific event.

• Brand Name: UNIVERS VAULTLOCK GLENOID, SMALL
• 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: 24673505
• Report Number: 1220246-2026-01615
• Device Sequence Number: 16006274
• Product Code: KWS
• UDI-Device Identifier: 00888867239319
• UDI-Public: (01)00888867239319(11)230201(17)280131(10)S81301073
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2026

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, SMALL
• Device Catalogue Number: AR-9106-01
• Device Lot Number: S81301073
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 07/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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