MAUDE Adverse Event Report:; REV DISTAL STM, 20X200MM

Catalog Number 428-20-200

Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Revision surgery - it was reported the patient's tapered distal stem that was implanted in (b)(6) of 2012 had fractured, so the patient was revised.The revision explanted the djo components and replaced with another manufacturers product.

• Type of Device: REV DISTAL STM, 20X200MM
• MDR Report Key: 11816685
• MDR Text Key: 250366494
• Report Number: 1644408-2017-00485
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 11/18/2020

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: 428-20-200
• Device Lot Number: 1004023
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention