MAUDE Adverse Event Report:; TURON PEGGED GLENOID IMPLANT, SIZE 50

Catalog Number 520-01-250

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Revision surgery - a total shoulder failure due to an irreparable rotator cuff tear; the surgeon revised to a reverse total shoulder.

• Type of Device: TURON PEGGED GLENOID IMPLANT, SIZE 50
• MDR Report Key: 11811768
• MDR Text Key: 250184610
• Report Number: 1644408-2016-00804
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 520-01-250
• Device Lot Number: 193G1099
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention