MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN GENESIS II TOTAL KNEE FEM COMP; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAIND, CEMENT, POLY/METAL/POLY

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thrombosis (2100); Thrombosis/Thrombus (4440)

Event Date 01/01/1901

Event Type  Injury  

Event Description

It was reported in the publication "the knee v21 2014 - the limited use of a tourniquet during total knee arthroplasty: a randomized controlled trial".That the study were 60 patients bearing s&n genesis ii system, that took place, that 6 patients suffered from a symptomatic deep vein thrombosis (dvt) in the calf, post -operative.

Manufacturer Narrative

The device, used for treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms the data presented in the aged article, "the knee v21 2014 - the limited use of a tourniquet during total knee arthroplasty: a randomized controlled trial.¿ based on the information provided, this article did not provide insight or relevance to current clinical outcomes for the product/device.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The root cause of the reported dvt and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.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.G1: contact address update.

• Brand Name: UNKN GENESIS II TOTAL KNEE FEM COMP
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAIND, CEMENT, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10767876
• MDR Text Key: 214094049
• Report Number: 1020279-2020-05981
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• 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: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GENESIS II TOTAL KNEE STEM; GENESIS II TOTAL KNEE TIB BASEPLATE; GENESIS II TOTAL KNEE TIB INSERT; GENESIS II TOTAL KNEE STEM; GENESIS II TOTAL KNEE TIB BASEPLATE; GENESIS II TOTAL KNEE TIB INSERT
• Patient Outcome(s): Other; Required Intervention