MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX ECLIPSE HUMERAL HEAD, 45/17; TOT ANAT SHOULDR PROSTH, UNCEM

Model Number ARTHREX ECLIPSE HUMERAL HEAD, 45/17

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 07/11/2023

Event Type  Injury  

Event Description

It was reported that a loosening of the pegged glenoid led to an explantation of the anatomic eclipse prosthesis and the pegged glenoid.No further information was provided.Update avoe (b)(6) 2023: it was confirmed that the initial surgery took place in 2015 in the privatklinik bethanien, 8044 zürich.After the eclipse and the pegged glenoid were explanted, these devices were replaced with devices from another manufacturer.

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, 45/17
• Type of Device: TOT ANAT SHOULDR PROSTH, UNCEM
• 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: emily shafer ; 8009337001
• MDR Report Key: 17486646
• MDR Text Key: 320665553
• Report Number: 1220246-2023-07461
• Device Sequence Number: 1
• Product Code: QHQ
• UDI-Device Identifier: 00888867060029
• UDI-Public: 00888867060029
• 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: 08/09/2023

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: ARTHREX ECLIPSE HUMERAL HEAD, 45/17
• Device Catalogue Number: AR-9345-17
• Device Lot Number: 1295130205
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/11/2023
• Initial Date FDA Received: 08/09/2023
• 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