MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE TRUNION 39MM, SLOTTED, TPS CAP; TOT ANAT SHOULDR PROSTH, UNCEM

Model Number	ECLIPSE TRUNION 39MM, SLOTTED, TPS CAP
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Subluxation (4525)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On 10-mar-2026, a clindex notification was received via email indicating that information had been obtained from a clinical study (shoulder arthroplasty registry, iirr 00608).The subject¿s initial shoulder arthroplasty procedure had been performed on (b)(6) 2026 using the eclipse implant system.According to the report, the subject had been seen in the office two weeks after the total shoulder arthroplasty.On physical examination, humeral subluxation was palpated anteriorly, which was reducible into the glenohumeral joint.X rays obtained during the visit demonstrated anterior inferior subluxation of the humerus.The subject did not report any trauma prior to the discovery of the subluxation.Non-operative management options, revision subscapularis repair, and conversion to reverse shoulder arthroplasty (rsa) were discussed with the subject.The subject elected to proceed with surgical management for the subscapularis failure.According to the report, the event was assessed as probably related to the devices.On 23 mar 2026, an updated clindex notification was received via email, indicating that the reported event was determined to be unrelated to the subject devices and that the revision procedure involved a different type of arthroplasty.On 24-mar-2026, follow up information was received in response to the additional questions submitted for clarification regarding the previously reported adverse event involving anterior humeral subluxation after a total shoulder arthroplasty performed on (b)(6) 2026 using the eclipse implant system.According to the updated report, the humeral subluxation was first identified on (b)(6) 2026 during the subject¿s postoperative follow up visit, consistent with the adverse event onset date.During physical examination, the shoulder was found to be grossly unstable anteriorly; the humeral head was reducible but would dislocate.The subject did not report any unusual activity, falls, trauma, or stress events between the index surgery and the postoperative visit.X-rays obtained on (b)(6) 2026 demonstrated anterior-inferior humeral subluxation; however, the clinical note was the only available interpretation, and no additional imaging modalities (ultrasound, ct, mri) were performed.The event was initially presumed to be related to a subscapularis failure, but intraoperative findings later confirmed that the subscapularis was intact.Intraoperative documentation from the (b)(6) 2026 procedure confirmed that the subscapularis repair via lesser tuberosity osteotomy had been performed as planned.At the time of the (b)(6) 2026 evaluation, the patient reported well controlled pain and no additional symptoms.The patient did not report any other instability episodes to the clinical team, and it remains unknown whether additional subluxation events occurred before or after the (b)(6) 2026 visit.Non-operative treatment was considered; however, the subject elected to proceed with surgical management.The patient subsequently underwent revision surgery on (b)(6) 2026, consisting of conversion to a reverse shoulder arthroplasty using a subscapularis peel approach.No intraoperative deviations were reported.The following implant components from the eclipse implant system and associated devices were confirmed to have been used during the initial (b)(6) 2026 procedure: an ar-9301-03 arthrex eclipse cage screw large, an ar-9301-39cpc eclipse trunion, an ar-9106-01 arthrex univers vaultlock glenoid, an ar-7297-2 fibertape tendon compression bridge kit, and an ar-9339-16 arthrex eclipse humeral head.No intraoperative deviations occurred during the index surgery.The investigator revised their assessment of device-relatedness; the event is now assessed as unrelated to the devices, as the healthcare provider was unsure of the cause of instability and subluxation.As of this follow-up submission, the subject underwent revision surgery on (b)(6) 2026, and no further postoperative follow-up has occurred.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: ECLIPSE TRUNION 39MM, SLOTTED, TPS CAP
• Common Device Name: TOT ANAT SHOULDR PROSTH, 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: 24741482
• Report Number: 1220246-2026-01732
• Device Sequence Number: 8694569
• Product Code: QHQ
• UDI-Device Identifier: 00888867276123
• UDI-Public: (01)00888867276123(11)241101(17)291031(10)24.01742
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K183194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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: ECLIPSE TRUNION 39MM, SLOTTED, TPS CAP
• Device Catalogue Number: AR-9301-39CPC
• Device Lot Number: 24.01742
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown