MAUDE Adverse Event Report: ARTHREX, INC. 35MM CENTRAL POST, MODULAR; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number 35MM CENTRAL POST, MODULAR

Device Problems Improper or Incorrect Procedure or Method (2017); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 12/09/2020

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 revision surgery was performed to retrieve the prosthesis.It was further reported that the defective prosthesis was caused due to the post operative actions by the patient.The patient did not follow the post op guidelines and was overloading the prosthesis too early in the gym.

Manufacturer Narrative

Complaint not confirmed, the device was returned with a large chunk of bone and/or bone cement but no apparent damage or abnormality that may contributed to the event was observed.As provided in the event description, the cause of the event is likely patient non-compliance.

• Brand Name: 35MM CENTRAL POST, MODULAR
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11153784
• MDR Text Key: 226255398
• Report Number: 1220246-2021-02469
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867296541
• UDI-Public: 00888867296541
• Combination Product (y/n): N
• 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: 09/02/2021

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: 35MM CENTRAL POST, MODULAR
• Device Catalogue Number: AR-9561-35P
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/28/2020
• Initial Date FDA Received: 01/12/2021
• Supplement Dates Manufacturer Received: 12/28/2020
• Supplement Dates FDA Received: 09/02/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other