MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN ANTHEM KNEE TIB BASEPLATE; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number UNKNOWN

Device Problems Break (1069); Material Separation (1562)

Patient Problem Failure of Implant (1924)

Event Date 06/30/2020

Event Type  Injury  

Event Description

It was reported that, after a tka performed 12 years after ago with an anthem system, a revision surgery was planned to replace the insert.After opening the joint, it turned out that the anthem tibial baseplate was broken.A full revision was performed to insert a competitor's system.

Manufacturer Narrative

H3, h6: it was reported that 12 years after the primary surgery, an insert replacement was planned.After opening the joint, it turned out that the anthem tibial baseplate was broken.A full revision was performed.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.A medical analysis noted pictures of the insert and the baseplate were provided which show uneven wear on the insert as well as fractured tibial base plate.Both components are very worn and damaged.Smith and nephew has not received the device or adequate materials (operative reports or possible trauma history) to fully evaluate the complaint.The impact to the patient cannot be determined with the limited information.Based on this investigation, the need for corrective action is not indicated.Some potential causes could include but are not limited to fit/sizing, traumatic injury or wear of device.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: UNKN ANTHEM KNEE TIB BASEPLATE
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10319445
• MDR Text Key: 200200758
• Report Number: 1020279-2020-03486
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K170648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention