MAUDE Adverse Event Report: UNICOMPARTMENTAL KNEE REPLACEMENT; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erosion (1750); Cyst(s) (1800); Hemorrhage/Bleeding (1888); Inflammation (1932); Pain (1994)

Event Date 06/29/2021

Event Type  Injury  

Event Description

Unicompartmental knee replacement experienced plastic erosion.My body responded to plastic particulates as foreign bodies with macrophage attack on inside of joint.(b)(6) 2021, inflammation led to formation of popliteal cyst.Cyst ruptured, leaking synovial fluid and blood into intramuscular space of calf muscles.On (b)(6) 2021 inflammation dissected between quadriceps and femur; extreme pain required er visit; crutches required until joint revision surgery (b)(6) 2021.When surgeon opened joint, all tissues were purple due to bleeding inside the joint.I have ehlers danlos hypermobility.Advised surgeon before (b)(6) 2017 surgery that unicompartmental replacement device was not ideal for my condition.Revision was completed with constrained full joint, and this is what should have been used the first time.Required surgical procedure.I'm writing because i believe someone needs to do a meta-analysis of outcomes for joint replacement surgery in patients with ehlers danlos hypermobility and similar genetic errors, to determine what medical implants are most safe and effective for long-term outcomes.If the surgeon had followed my advice as a person living with these knees, performing a total knee replacement the first time, i would not have lost 8 months of my life to severe pain, muscles atrophying as i was stuck on crutches, all aspects of health declining as i spent the majority of my life laying down with my leg up on a pillow.Clear fda guidance on implants to be used for patients with hypermobility are needed because we make up the majority of people with a need for joint replacements at an early age.Revision surgery is more complex and dangerous than original replacement surgery.Mental health medication i don't feel like listing.Fda safety report id# (b)(4).

• Brand Name: UNICOMPARTMENTAL KNEE REPLACEMENT
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• MDR Report Key: 14022203
• MDR Text Key: 288832495
• Report Number: MW5108800
• Device Sequence Number: 1
• 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: 04/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: ONGOING DICLOFENAC DAILY FOR EDS INFLAMMATION
• Patient Outcome(s): Disability; Hospitalization; Required Intervention; Other
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White