MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE SHOULDER PROSTHESIS; TOT ANAT SHOULDR PROSTH, UNCEM

Model Number ECLIPSE CAGE SCREW L, 40MM

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Date 06/04/2020

Event Type  malfunction  

Event Description

On july 11, 2022, a notification was received indicating that a patient, listed on the shoulder arthroplasty registry, is experiencing worsening pain.An x-ray shows a dislodged glenoid component.Surgeon has scheduled the patient for a revision surgery to an rsa on (b)(6) 2022.Original surgery took place on (b)(6) 2020.Additional information received on 7/12/2022: during surgery on (b)(6) 2020, a total of 4 arthrex devices were implanted.An ar-9301-03 eclipse cage screw large, lot number 19.00501, an ar-9301-43cpc eclipse trunion, lot number 18-01245, an ar-9343-16 eclipse humeral head, lot number 1917001, and an ar-9106-01 univers vaultlock glenoid.As of now, nothing has shown to be broken inside the patient but there's as dislodgment of glenoid prosthesis.Additional information received on 7/25/2022: according to facility representative, patient experience cardiac events during the pre-op area and revision surgery did not take place.At this time, it is unknown if patient will undergo revision surgery.Additional information received on 12/30/2022: the revision surgery that was to take place on (b)(6) 2022, was cancelled due to cardiac co-morbidities.No further information has been provided.

Manufacturer Narrative

The device was not returned for evaluation; no pictures were provided.The most likely cause for the reported failure can be attributed to a patient-specific event.

• Brand Name: ECLIPSE SHOULDER PROSTHESIS
• Type of Device: 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: 18666666
• MDR Text Key: 334836972
• Report Number: 1220246-2024-00844
• Device Sequence Number: 1
• Product Code: QHQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/08/2024

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
• Device Operator: Health Professional
• Device Model Number: ECLIPSE CAGE SCREW L, 40MM
• Device Catalogue Number: AR-9301-03
• Device Lot Number: 19.00501
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1