MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. AGENESIS II ARTICUALAR INSERT; TEMPLATE

Catalog Number 71421509

Device Problem Mechanics Altered (2984)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/26/2019

Event Type  malfunction  

Event Description

The patient sustained mechanical fall at home and was found extrusion of polyethylene.

• Brand Name: AGENESIS II ARTICUALAR INSERT
• Type of Device: TEMPLATE
• Manufacturer (Section D): SMITH AND NEPHEW, INC.
• MDR Report Key: 9631995
• MDR Text Key: 176669408
• Report Number: MW5092496
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71421509
• Device Lot Number: 19LM15656 SIZE 3-4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 96