MAUDE Adverse Event Report: BIOMET, INC. VANGUARD TOTAL KNEE REPLACEMENT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Health Effect - Clinical Codes	Arthritis (1723); High Blood Pressure/ Hypertension (1908); Failure of Implant (1924); Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	03/03/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient called to report an adverse event involving her left side vanguard knee replacement she had implanted on (b)(6) 2020.Patient stated she is experiencing many issues since the device was implanted such as pain, limited range of motion, balance problems, difficulty standing and walking, getting up and bending.Patient stated her left foot is positioned inward and it feels like something is not aligned correctly.Patient stated she¿s in constant pain and it feels like someone took a jackhammer to her knee.She also stated she has been experiencing left ankle and knee swelling, elevated blood pressure reaching 200/110 and trouble bearing weight.Patient stated nobody wants to help her and deal with her adverse event.She stated she was told by the doctor to go for a walk or ride a bike and feels she is being dismissed.Patient said she was told she has developed severe osteoarthritis and that is the reason for her pain.Patient stated this has degraded her quality of life and she is desperately seeking a doctor to help her.

• Brand Name: VANGUARD TOTAL KNEE REPLACEMENT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): BIOMET, INC.
• MDR Report Key: 19310920
• Report Number: MW5154797
• Device Sequence Number: 19399117
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 05/13/2024

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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2024
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Female