MAUDE Adverse Event Report:; DISC CONDYLE KIT WITH HEXALOBULA

Catalog Number 114700

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Revision surgery - due to the humeral component being replaced with a longer stem because it was loosening.

• Type of Device: DISC CONDYLE KIT WITH HEXALOBULA
• MDR Report Key: 10649492
• MDR Text Key: 210449968
• Report Number: 1644408-2016-00422
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 114700
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention