MAUDE Adverse Event Report: ARTHROSURFACE, INC. PF WAVE IMPLANT UNICOMPARTMENTAL PATELLOFEMORAL JOINT - PRESS FIT 10 X 5 TROCHLE; PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); Pain (1994); Anxiety (2328); Ambulation Difficulties (2544)

Event Date 06/24/2021

Event Type  Injury  

Event Description

In 2012 arthroscopic surgery was completed on my right knee with little relief of pain.Both of my kneecaps were replaced by an orthopedic surgeon in (b)(6).Rt knee cap (b)(6) 2016, left kneecap (b)(6) 2017.Continued pain in both knees.Due to unusual pain in the left knee earlier this year, in (b)(6) 2021 x-rays revealed a defect in the left prosthetic; total left knee replacement (tkr) in (b)(6) 2021.Pt for 3 months and continued water therapy.In (b)(6) 2021, x-rays revealed a "prominent patella alta" of the right knee and doctors are recommending a tkr of the right knee.I have not had a traumatic injury to my knees.During shelter in place guidelines, my activity was limited.With increased pain in my knees and being diagnosed with compromising medical issues, my activity & mobility is still limited.Research states the arthrosurface kneecap prosthetics should last 15-20 years.A certified letter was sent to arthrosurface september 14, 2021, received on 9-20-2021.No response until i contacted arthrosurface on 9-30-2021.After our initial conversation, no response from the senior attorney, even after several attempts to contact him until november 8, 2021.A letter was received by emailed denying any issues with their implants.I'm still recovering from a tkr in (b)(6) after the removal of defective implant from my left knee.Another tkr is required in the near future to remove the implant that is no longer in the proper position in my right knee.Due to diagnosis of chronic kidney disease, sle, and other compromising medical issues, i'm having to endure increased pain and anxiety as i wait for my body to recover from my most recent knee surgery.The surgical notes from (b)(6) 2021 revealed that the implant was completely broken and we are not sure what will be revealed when surgery is completed on the right knee.My present orthopedic prescribed a large brace due to the prominent patella alta revealed on my x-rays of "(b)(6) 2021".Fda safety report id# (b)(4).

• Brand Name: PF WAVE IMPLANT UNICOMPARTMENTAL PATELLOFEMORAL JOINT - PRESS FIT 10 X 5 TROCHLE
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): ARTHROSURFACE, INC.
• MDR Report Key: 13002325
• MDR Text Key: 282386253
• Report Number: MW5106026
• Device Sequence Number: 2
• Product Code: KRR
• 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: 12/10/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: AMLODIPINE; APPLE CIDER VINEGAR; ATENOLOL; CALCIUM; MAGNESIUM; MULTIVITAMINS; RIGHT PATELLOFEMORAL IMPLANT; VITAMIN C, D
• Patient Outcome(s): Disability; Required Intervention; Hospitalization; Other
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American