MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE TRUNION,45 MM TPS CTD; TOT ANAT SHOULDR PROSTH, UNCEM

Model Number ECLIPSE TRUNION,45 MM TPS CTD

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 01/07/2021

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to a loosening of the glenoid component and a central glenoid defect.No further information received.Update: 11-feb-2021.Further information was provided that the initial surgery was performed on (b)(6) 2014.Update: 11-may-2021.Further information was provided that the rotator cuff was intact.The patient was able to use his shoulder perfectly after the primary surgery.By the time the situation became worse, the patient was treated tornier with an aequalis reversed ii with glenoid femoral allograft.

Manufacturer Narrative

Complaint not confirmed, no abnormalities were observed that may have contributed to the event.

• Brand Name: ECLIPSE TRUNION,45 MM TPS CTD
• 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: 18005079
• MDR Text Key: 326515048
• Report Number: 1220246-2023-08373
• Device Sequence Number: 1
• Product Code: QHQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K183194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/25/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: ECLIPSE TRUNION,45 MM TPS CTD
• Device Catalogue Number: AR-9300-45CPC
• Device Lot Number: 2501305607
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other