MAUDE Adverse Event Report:; HEAD, HUMERAL, OFFSET, 42-20

Catalog Number 520-42-120

Device Problem Improper or Incorrect Procedure or Method (2017)

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 - due to a patient non-compliance issue; they didn't conform to weight restrictions and didn't wear sling.The soft tissue failed.

• Type of Device: HEAD, HUMERAL, OFFSET, 42-20
• MDR Report Key: 10542663
• MDR Text Key: 207219203
• Report Number: 1644408-2016-00257
• 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: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 520-42-120
• Device Lot Number: 915C1047
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention