MAUDE Adverse Event Report:; TURON PEGGED GLENOID, SZ 42MM, EPLUS

Catalog Number 521-01-242

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Corrected data: original initial report was submitted as follow up in error.

Event Description

Revision surgery - due to an infection.The patient presented with pain in the right shoulder that was a result of an infection confirmed through aspiration.The implants were removed and the patient will be scheduled for second stage revision in 3 months.No implants were implanted at this time.

• Type of Device: TURON PEGGED GLENOID, SZ 42MM, EPLUS
• MDR Report Key: 11819670
• MDR Text Key: 250606716
• Report Number: 1644408-2018-00480
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 521-01-242
• Device Lot Number: 799N1048
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention