MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX ECLIPSE HUMERAL HEAD, 43/16; TOT ANAT SHOULDR PROSTH, UNCEM

Model Number ARTHREX ECLIPSE HUMERAL HEAD, 43/16

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Date 06/04/2020

Event Type  malfunction  

Manufacturer Narrative

Complaint not confirmed.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.

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 a dislodgment of glenoid prosthesis.Additional information received on 7/25/2022: according to facility representative, patient experienced 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.

• Brand Name: ARTHREX ECLIPSE HUMERAL HEAD, 43/16
• 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: emily shafer ; 8009337001
• MDR Report Key: 18439574
• MDR Text Key: 332611523
• Report Number: 1220246-2024-00066
• Device Sequence Number: 1
• Product Code: QHQ
• UDI-Device Identifier: 00888867060005
• UDI-Public: 00888867060005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183194
• 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: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: ARTHREX ECLIPSE HUMERAL HEAD, 43/16
• Device Catalogue Number: AR-9343-16
• Device Lot Number: 1917001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2019
• 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
• Treatment: AR-9301-03, AR-9301-43, AR-9106-01