MAUDE Adverse Event Report:; INSERT, REVISION EXPRT, SZ A X 17MM, E-PLUS

Catalog Number 315-0A-717

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Revision surgery - due to the patient having a drifting patella from the original surgery.The surgeon went in to remove it and during the surgery decided to do a poly exchange, so he could put in a new liner.Upon removal there was nothing wrong with the djo product just with the patella from the original surgery which wasn't from djo.

• Type of Device: INSERT, REVISION EXPRT, SZ A X 17MM, E-PLUS
• MDR Report Key: 10686948
• MDR Text Key: 211643887
• Report Number: 1644408-2016-00458
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 315-0A-717
• Device Lot Number: 005R1004
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention