MAUDE Adverse Event Report:; ENCORE REVERSE SHOULDER HUMERAL STEM, LARGE SHELL, SZ 10, REVISION, 175MM

Catalog Number 530-10-175

Device Problems Loose or Intermittent Connection (1371); 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 humeral component was loosening causing the revision.

• Type of Device: ENCORE REVERSE SHOULDER HUMERAL STEM, LARGE SHELL, SZ 10, REVISION, 175MM
• MDR Report Key: 10806446
• MDR Text Key: 215261564
• Report Number: 1644408-2016-00865
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 10/30/2020

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: 530-10-175
• Device Lot Number: 410T1001
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/08/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention