MAUDE Adverse Event Report:; ENCORE REVERSE SHOULDER HUMERAL STEM, STD, SZ14X108MM

Catalog Number 530-14-108

Device Problems Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Original initial report was submitted as follow up in error.

Event Description

Revision surgery - due to implant migration and potential infection.

• Type of Device: ENCORE REVERSE SHOULDER HUMERAL STEM, STD, SZ14X108MM
• MDR Report Key: 11819653
• MDR Text Key: 250596596
• Report Number: 1644408-2018-00493
• 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: 12/04/2020

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: 530-14-108
• Device Lot Number: 415T1053
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/13/2021
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention