MAUDE Adverse Event Report: SMITH AND NEPHEW ORTHOPAEDICS AG VISIONAIRE; PROSTHESIS, KNEE

Device Problems Break (1069); Loose or Intermittent Connection (1371); Noise, Audible (3273)

Patient Problems Edema (1820); Inflammation (1932); Pain (1994); Skin Discoloration (2074); Osteolysis (2377); Ambulation Difficulties (2544)

Event Date 04/13/2015

Event Type  Injury  

Event Description

Caller called to report having two knee replacements due to a loose hinge and broken hardware; the first surgery was (b)(6) 2015, then again (b)(6) 2017 for the same problems.The caller now has clicking sound in the knee joint, fluid retention, progressive bone deterioration, skin discoloration, inflammation, ambulation difficulties, unable to socialize with friends, family, and isn't able to clean his home because of pain.Caller states that due to the bone deterioration his doctor has told him that his leg will need to be amputated.Caller has an appointment with his orthopedic (b)(6) 2018 and states that he has spoken to an attorney to help him with getting his medical record.

• Brand Name: VISIONAIRE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): SMITH AND NEPHEW ORTHOPAEDICS AG
• MDR Report Key: 7365810
• MDR Text Key: 103461075
• Report Number: MW5076035
• Device Sequence Number: 2
• Product Code: HSX
• 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: 03/22/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 45 YR
• Patient Weight: 107