MAUDE Adverse Event Report:; STEM, HUMERAL SIZE6 RSP

Catalog Number 506-00-006

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Revision surgery - due to the surgeon finding that the stem was loosening and that there also could be a potential for infection.The representative indicated that the original surgery used the modular system so 4 items came out, but only 3 went in during the revision.

• Type of Device: STEM, HUMERAL SIZE6 RSP
• MDR Report Key: 11819604
• MDR Text Key: 250599328
• Report Number: 1644408-2018-00594
• 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: 12/08/2020

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: 506-00-006
• Device Lot Number: 53994259
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention