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

Catalog Number 114904

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Revision surgery - according to the surgeon, loosening of humeral component was possibly due to patient poor bone quality because of rheumatoid arthritis.

• Type of Device: DISC HUM 4X100MM LT FLANGED C
• MDR Report Key: 11823321
• MDR Text Key: 250602800
• Report Number: 1644408-2016-00831
• 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: 10/29/2020

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: 114904
• Device Lot Number: 941450
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention