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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 01/14/2020

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.

Event Description

It was reported that a revision surgery was needed after the primary implantation which was performed in 2015.The eclipse prostheses was removed and replaced with a univers revers prostheses.No further information were currently provided.

Manufacturer Narrative

This is a follow-up submission to reflect additional details.Further information were received that the revision surgery was performed due to pain and movement restrictions.It was found that the device was degraded.The revision surgery was successful, due to a higher bone loss a bone block was inserted on the glenoid side.

• 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
• MDR Report Key: 9659121
• MDR Text Key: 189823662
• Report Number: 1220246-2020-01645
• Device Sequence Number: 1
• Product Code: QHQ
• Combination Product (y/n): N
• PMA/PMN Number: K183194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/31/2020

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 Model Number: ECLIPSE TRUNION,47 MM TPS CTD
• Device Catalogue Number: AR-9300-47CPC
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 02/03/2020
• Supplement Dates Manufacturer Received: 01/14/2020
• Supplement Dates FDA Received: 03/31/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other