MAUDE Adverse Event Report: ARTHREX, INC. AR-9300-49CPC; TOTAL SHOULDER ARTHROPLASTY SYSTEM

Model Number AR-9300-49CPC

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

Patient Problem No Code Available (3191)

Event Date 01/15/2020

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.

Event Description

It was reported that a revision shoulder surgery was performed on (b)(6) 2020.The glenoid got loose post op.No further information provided by the customer.The device will not return for investigation.Update 05-mar-2020: further information was provided that the initial surgery was performed on (b)(6) 2014.Update 06-aug-2020: further information were provided that the following devices were also explanted during the initial revision surgery.Ar-9347-18 batch 1295131706.Ar-9300-47cpc batch12.744.Ar-9301-02 batch 13.389.

Manufacturer Narrative

Complaint not confirmed, no abnormality was observed on the device that may have contributed to the event.

• Brand Name: AR-9300-49CPC
• Type of Device: TOTAL SHOULDER ARTHROPLASTY SYSTEM
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10431437
• MDR Text Key: 203833879
• Report Number: 1220246-2020-02070
• Device Sequence Number: 1
• Product Code: QHQ
• Combination Product (y/n): N
• PMA/PMN Number: K183194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AR-9300-49CPC
• Device Catalogue Number: AR-9300-47CPC
• Device Lot Number: 12.744
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/06/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other