MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE TRUNION 45MM, SLOTTED, TPS CAP; TOTAL SHOULDER ARTHROPLASTY SYSTEM

Model Number ECLIPSE TRUNION 45MM, SLOTTED, TPS CAP

Device Problem Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2021

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 during a total shoulder arthroplasty, when the surgeon was going to use the eclipse, it was not sitting well and the surgeon diverted to an univers head and apex stem.No patient harm.

• Brand Name: ECLIPSE TRUNION 45MM, SLOTTED, TPS CAP
• 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: 12306237
• MDR Text Key: 265975044
• Report Number: 1220246-2021-03509
• Device Sequence Number: 1
• Product Code: QHQ
• UDI-Device Identifier: 00888867276154
• UDI-Public: 00888867276154
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/11/2021

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 45MM, SLOTTED, TPS CAP
• Device Catalogue Number: AR-9301-45CPC
• Device Lot Number: 19.04117
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/22/2021
• Initial Date FDA Received: 08/11/2021
• Date Device Manufactured: 05/01/2020
• 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