MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION TOTAL KNEE REPLACEMENT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Device Problems Unstable (1667); Patient-Device Incompatibility (2682); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577)

Event Date 07/12/2016

Event Type  Injury  

Event Description

Patient called to report an adverse event involving his legion total knee replacement.Patient stated since it was implanted on (b)(6) 2016, he has experienced instability, pain, swelling, sickness, and is barely able to walk and get around.Patient stated when he stands in one spot, his knee will let go and it feels like he could fall at any time.Patient stated he was given a walker to assist with walking, and goes to the gym to try and help, but overall he feels the device is not satisfactory and has not helped him.Patient stated that if he could go back, he would never have had the knee replacement at all.

• Brand Name: LEGION TOTAL KNEE REPLACEMENT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.
• MDR Report Key: 13258102
• MDR Text Key: 283974644
• Report Number: MW5106677
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/13/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Sex: Male