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 Insufficient Information (4580)

Event Date 04/28/2020

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed with an arthrex product involved.No further information was provided.Update 14-may-2020, asa: confirmation received that performed surgery was a revision of an eclipse with an peg-glenoide five years after initial surgery.No further information has been made available.

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.

• 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: 15137829
• MDR Text Key: 296951338
• Report Number: 1220246-2022-05319
• 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: 08/01/2022

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
• Device Lot Number: 13.807
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/14/2022
• Initial Date FDA Received: 08/01/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other