MAUDE Adverse Event Report: ARTHREX, INC.; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number AR-9105-X

Device Problems Break (1069); Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/02/2020

Event Type  malfunction  

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.

Event Description

It was reported that a planned shoulder revision surgery of an eclipse shoulder prosthesis was performed.Initial surgery was performed in 2015 by the same surgeon.Rotator cuff was intact, eclipse was replaced by an anatomic prosthesis type "mirai".Images of the devices provides show heavy wear and tear of the glenoid ar-9105-0x (exact size unknown) and broken peg.During the revision the following parts were explanted: ar-9105-0x, ar-9301-03, ar-9351-19, ar-9300-51.No more information has been made available.

Manufacturer Narrative

Complaint confirmed, the pegged glenoid is damaged: both pegs are broken, the device is worn and cracked around the edges.The cause of the event is undetermined.

• Brand Name: UNK
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10567128
• MDR Text Key: 207954138
• Report Number: 1220246-2020-02201
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K083435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AR-9105-X
• Device Catalogue Number: AR-9105-X
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/03/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other