MAUDE Adverse Event Report: SMITH AND NEPHEW INC ARTICULAR SURFACE SIZE 2 9MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 00584200201

Device Problem Insufficient Information (3190)

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

Event Date 08/17/2018

Event Type  Injury  

Event Description

It was reported that revision surgery was performed, uni knee revised to journey ii primary knee.

Manufacturer Narrative

The associated complaint devices were not returned.A clinical evaluation was conducted and no clinical relevant documents were provided to conduct a thorough medical assessment.No medical assessment is warranted at this time.This complaint will be re-evaluated if more information becomes available.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: ARTICULAR SURFACE SIZE 2 9MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH AND NEPHEW INC; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7858746
• MDR Text Key: 119640221
• Report Number: 1020279-2018-01759
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00885556620045
• UDI-Public: 00885556620045
• Combination Product (y/n): N
• PMA/PMN Number: K033363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00584200201
• Device Lot Number: 62773923
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/17/2018
• Initial Date FDA Received: 09/09/2018
• Supplement Dates Manufacturer Received: 11/03/2018; 11/03/2018
• Supplement Dates FDA Received: 11/05/2018; 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention