MAUDE Adverse Event Report: CORENTEC AMERICA FEMORAL COMPONENT; KNEE PROSTHESIS

Lot Number 111011011

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Swelling (2091); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

Had a total knee replacement (b)(6) 2012.After my knee was unwrapped, my leg was crooked.Had a hard time walking.A lot of pain.Then, in (b)(6) 2014, i had a revised surgery and i'm still in severe pain and having problem with my knee.After total knee replacement my leg was totally crooked and swollen for over 2 years.Severe pain, trouble walking and more.

• Brand Name: FEMORAL COMPONENT
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): CORENTEC AMERICA
• MDR Report Key: 5546836
• MDR Text Key: 41978239
• Report Number: MW5061452
• Device Sequence Number: 6
• Product Code: JDI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 111011011
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 122