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

Device Problem Nonstandard Device (1420)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Date 06/10/2016

Event Type  Injury  

Event Description

On about (b)(6) 2013 or 2014 i received a total knee replacement.The operation was located at (b)(6) hospital in (b)(6).I wasn't informed of the brand/model of the implant.I had questioned surgeon about the brand and with he gave no reply.After years of pain, suffering and being traumatized i have some my own research with the findings of the actual brand of the implant named biomet (vanguard.Its size 65.) i did this because i was not informed of the recall for this implant.Due to being traumatized from the surgery, i was reluctant to receive medical care in fear of having to have corrective surgery in pain not knowing my options.I am highly upset about (no notification ) of the recall.I will not have revision surgery due to additional pain and suffering i would have to endure.My symptoms i have had for the past several years are swelling bellow and above the knee, popping, rattling and limited time i can stand with out it swelling and even trying to bend it when walking.The only medication i use to try to subdue the pain is ibuprofen.Also i do have numerous pinched nerves and carpal tunnel in both hands also i am 98% deaf in right ear and approximately 75% deaf in my left ear.I will be going to seek options and opinions from orthopedic surgeons but i do want to get this on record and i am asking for a representative to contact me.The above dates are estimates due to the fact i do not have current access to those medical records.I do not have records i can access to put the tests on here.I spoke with fda on 2/10/2023 to confirm the biomet vanguard is a recall as of january 4, 2017.I currently have the recalled implant in my leg for further discussion please contact me at (b)(6), please leave a voicemail with a number and name due to spam calls.I will return your call after receiving voicemail.

• Brand Name: LEFT TOTAL KNEE REPLACEMENT BIOMET VANGUARD
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): BIOMET, INC.
• MDR Report Key: 16380632
• MDR Text Key: 309745164
• Report Number: MW5114962
• Device Sequence Number: 1
• Product Code: JWH
• 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: 02/10/2023

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?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2023
• Patient Sequence Number: 1
• Treatment: ENSURE SUPPLEMENTAL NUTRITION SHAKE; IBUPROFEN; MAGNESIUM; MULTIVITAMIN; TYLENOL
• Patient Outcome(s): Disability; Other
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White