MAUDE Adverse Event Report:; SHELL, BIPOLAR, MODULAR, ENCORE, SIZE50

Catalog Number 412-02-050

Device Problem Appropriate Term/Code Not Available (3191)

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 an infection.

• Type of Device: SHELL, BIPOLAR, MODULAR, ENCORE, SIZE50
• MDR Report Key: 11816665
• MDR Text Key: 250349516
• Report Number: 1644408-2017-00501
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 11/18/2020

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: 412-02-050
• Device Lot Number: 997B1060
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention