MAUDE Adverse Event Report:; DISC CONDYLE KIT WITH HEXALOBULA

Catalog Number 114700

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); 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 the hemi stem breaking through the cortiel ball mid hemurs.The patient also had an infection.The original date of surgery is unknown, the representative advised that it was between 2007-2009.

• Type of Device: DISC CONDYLE KIT WITH HEXALOBULA
• MDR Report Key: 10614455
• MDR Text Key: 209423308
• Report Number: 1644408-2016-00352
• 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: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• 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