MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE TRUNION,47 MM TPS CTD; TOTAL SHOULDER ARTHROPLASTY SYSTEM

Model Number ECLIPSE TRUNION,47 MM TPS CTD

Device Problem Degraded (1153)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/11/2021

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported that one year after the implantation of a right shoulder total endo-prosthesis eclipse on (b)(6) 2016, polyethylene degradation was identified post-operatively.This resulted in a bone defect which led to a revision surgery to change the implant to an inverse prosthesis.

• Brand Name: ECLIPSE TRUNION,47 MM TPS CTD
• Type of Device: TOTAL SHOULDER ARTHROPLASTY SYSTEM
• 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: vik bajnath ; 8009337001
• MDR Report Key: 14337546
• MDR Text Key: 291228093
• Report Number: 1220246-2022-04890
• Device Sequence Number: 1
• Product Code: QHQ
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: ECLIPSE TRUNION,47 MM TPS CTD
• Device Catalogue Number: AR-9300-47CPC
• Device Lot Number: 150042112
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other