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

Catalog Number 114904

Device Problems Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Hematoma (1884)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Revision surgery - patient status post 10-12 years from primary elbow replacement.The patient fell and fractured her humerus (mid shaft).The revision surgery was performed to fix the fracture and asses stability of components.The humeral component was found to be loose; the surgeon revised to a 200 length revision stem with no issues.

• Type of Device: DISC HUM 4X100MM LT FLANGED C
• MDR Report Key: 10706852
• MDR Text Key: 212175135
• Report Number: 1644408-2016-00527
• 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: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 114904
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention