MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX ECLIPSE HUMERAL HEAD, 47/18; TOTAL SHOULDER ARTHROPLASTY SYSTEM

Model Number ARTHREX ECLIPSE HUMERAL HEAD, 47/18

Device Problem Degraded (1153)

Patient Problem Failure of Implant (1924)

Event Date 10/11/2021

Event Type  Injury  

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.

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: ARTHREX ECLIPSE HUMERAL HEAD, 47/18
• 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: 14337532
• MDR Text Key: 291374856
• Report Number: 1220246-2022-04889
• Device Sequence Number: 1
• Product Code: QHQ
• UDI-Device Identifier: 00888867060043
• UDI-Public: 00888867060043
• 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: 10/31/2020
• Device Model Number: ARTHREX ECLIPSE HUMERAL HEAD, 47/18
• Device Catalogue Number: AR-9347-18
• Device Lot Number: 1545001
• 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