MAUDE Adverse Event Report: ARTHREX, INC.; TOT ANAT SHOULDR PROSTH, UNCEM

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Joint Dislocation (2374)

Event Date 06/01/2023

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

On 03/11/2024, a clindex notification was received indicating that a dislocation occurred that resulted in medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function of a patient listed on the shoulder arthroplasty registry.This event was initially indicated as probably related to the eclipse devices, implanted on (b)(6) 2022, or the study the patient was part of.

• Brand Name: UNK
• 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: jared engle ; 8009337001
• MDR Report Key: 18982118
• MDR Text Key: 338636785
• Report Number: 1220246-2024-01678
• Device Sequence Number: 1
• Product Code: QHQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: No
• 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