MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX ECLIPSE HUMERAL HEAD, 49/20; TOT ANAT SHOULDR PROSTH, UNCEM

Model Number ARTHREX ECLIPSE HUMERAL HEAD, 49/20

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

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

Event Date 05/26/2023

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.

Event Description

It was reported that a revision shoulder surgery was performed due to loosening and abrasion of the glenoid component.Update avoe 06-jun-2023.It was further reported that the initial surgery took place in 2015 at the (b)(6).During the revision surgery on (b)(6) 2023 the patient was treated with a conversion to an inverse ascend from stryker.

• Brand Name: ARTHREX ECLIPSE HUMERAL HEAD, 49/20
• 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: 17170758
• MDR Text Key: 317633927
• Report Number: 1220246-2023-06945
• Device Sequence Number: 1
• Product Code: QHQ
• UDI-Device Identifier: 00888867060074
• UDI-Public: 00888867060074
• 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: 06/21/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: ARTHREX ECLIPSE HUMERAL HEAD, 49/20
• Device Catalogue Number: AR-9349-20
• Device Lot Number: 1295121802
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/26/2023
• Initial Date FDA Received: 06/21/2023
• Date Device Manufactured: 11/12/2012
• 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