MAUDE Adverse Event Report:; HEAD, HUMERAL, NEUTRAL, 50-18

Catalog Number 520-50-018

Device Problems Appropriate Term/Code Not Available (3191); Material Split, Cut or Torn (4008)

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 - due to a torn rotator cuff; failed total shoulder.

• Type of Device: HEAD, HUMERAL, NEUTRAL, 50-18
• MDR Report Key: 10806462
• MDR Text Key: 215262384
• Report Number: 1644408-2016-00883
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 11/02/2020

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: 520-50-018
• Device Lot Number: 53990647
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention