MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL INSERT M/39 +3 TO FIT IN 39 CUP; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number HUMERAL INSERT M/39 +3 TO FIT IN 39 CUP

Device Problems Material Protrusion/Extrusion (2979); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 03/16/2021

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 revision was necessary after a distal protrusion of the long humeral shaft.The patient will be rehabilitated at a later date after a humeral bone grafting procedure.The base plate including screws have remained in the patient.No further information were provided.

Manufacturer Narrative

Complaint confirmed.X-ray provided shows the bone protrusion.The humeral insert was found to be damaged, likely due to the misalignment of the humeral implant as a result of the protrusion observed on the x-ray.The cause of the protrusion is undetermined.

• Brand Name: HUMERAL INSERT M/39 +3 TO FIT IN 39 CUP
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11630240
• MDR Text Key: 244297212
• Report Number: 1220246-2021-02852
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867061255
• UDI-Public: 00888867061255
• Combination Product (y/n): N
• PMA/PMN Number: K142863
• 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: 05/21/2021

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: HUMERAL INSERT M/39 +3 TO FIT IN 39 CUP
• Device Catalogue Number: AR-9503M-03
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 04/07/2021
• Supplement Dates Manufacturer Received: 03/18/2021
• Supplement Dates FDA Received: 05/21/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other