MAUDE Adverse Event Report: BIOMET VANGUARD KNEE SYSTEM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Device Problems Loose or Intermittent Connection (1371); Defective Component (2292); Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Loss of Range of Motion (2032); Deformity/ Disfigurement (2360); Unspecified Mental, Emotional or Behavioural Problem (4430); Implant Pain (4561); Swelling/ Edema (4577)

Event Date 07/07/2015

Event Type  Other  

Event Description

Attune litigation record received.Litigation record alleges defective depuy attune knee system, defective smartset hv bone cement 40g, pain, swelling, joint stiffness, nickel allergy, suffering, impairment, disfigurement, pecuniary loss, economic damages and loosening of the tibial component at an unknown interface and aseptic loosening.Depuy cement were used.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).Ref report: mw5119584.

• Brand Name: VANGUARD KNEE SYSTEM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): BIOMET
• MDR Report Key: 17349973
• MDR Text Key: 319386160
• Report Number: MW5119585
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1