MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENGAGE CEMENTLESS PARTIAL KNEE; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL/UNICONDYLAR, UNCEMENTED, POROUS

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Ambulation Difficulties (2544)

Event Date 03/07/2023

Event Type  Injury  

Event Description

I had a left partial knee replacement surgery using the engage cementless knee replacement on (b)(6) 2023.I experienced agonizing pain and the implant felt loose.An mri (magnetic resonance imaging) revealed that the implant was loose on the femur and tibia, i had chronic bleeding, and my kneecap was in pieces.I had total knee revision on (b)(6) 2023 to remove the engage implant.I also have the engage implant in my right knee that was implanted on (b)(6) 2021.It has always caused me pain and now it's causing me agonizing pain and limits my ability to walk.Reference report: mw5153072.

• Brand Name: ENGAGE CEMENTLESS PARTIAL KNEE
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL/UNICONDYLAR, UNCEMENTED, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.
• MDR Report Key: 18968675
• MDR Text Key: 338609480
• Report Number: MW5153073
• Device Sequence Number: 1
• Product Code: NJD
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Hispanic
• Patient Race: White