MAUDE Adverse Event Report:; DISC HUM 4X100MM LT FLANGED C

Catalog Number 114904

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

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 - the patient was working in the yard and felt something in their elbow.After the surgeon had x-rayed the patient's elbow, it was apparent there was a periprosthetic fracture at the distal tip of the ulnar implant.

• Type of Device: DISC HUM 4X100MM LT FLANGED C
• MDR Report Key: 10806506
• MDR Text Key: 215263287
• Report Number: 1644408-2016-00909
• 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: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 114904
• Device Lot Number: 364600
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention