MAUDE Adverse Event Report: CORENTEC CO., LTD. CORENTEC LOSPA SIZE 6-KNEE PROSTHESIS; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Health Effect - Clinical Codes	Failure of Implant (1924); Damage to Ligament(s) (1952); Pain (1994); Paralysis (1997); Unspecified Kidney or Urinary Problem (4503)
Date of Event	07/03/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
I had knee replacement surgery and subpar prosthesis was used.The product name was corentec lospa prothesis.It fell apart in 2 years and required revision surgery with a commonly used zimmer prosthesis.(b)(6) 2021 revision surgery notes as they are written in operative report: "post was almost jumping in approximately 50 degrees of flexion with a varus thrust.The patella button fell out onto the floor.The cement had no fixation to the femur whatsoever.Cement did remain on the bone.Previous tibia was in a significant amount of varus.The patella measured approximately 5 mm.Did not resect the patella as it was already quite thin at its lowest point of about 4-5 mm and at the upper thickest point of about 10-12 mm." (b)(6) 2021 xray showed that the knee cap and the prothesis were both fractured completely in half (b)(6) 2021 surgery to incorporate a knee implant (zimmer) (b)(6) 2021 surgery to repair stretched ligaments on both sides of knee that caused excessive mobility, loosening of the knee.Surgeon implanted larger spacer to stretch the ligaments (b)(6) 2022 repeated office visits to report knee pain and in addition began to experience excruciating nerve pain from my buttocks (sciatic nerve) down to my ankle and a decrease in mobility.Surgeon said "there is structurally nothing wrong.Your knee is not causing the pain." (b)(6) 2022 knee procedure-nerve destruction by neurolytic agent (b)(6) 2023 knee procedure-nerve destruction by neurolytic agent (b)(6) 2023 lumbar procedure-epidural steroid injection (had negative reaction and temporary paralysis) (b)(6) 2023 xrays were taken and i was informed that the prosthetic knee implant was detached and was rolling in all directions in the knee cavity.A replacement knee implant or implant removal will be necessary to stop the pain and increase my mobility.I have chronic kidney disease from taking ibuprofen for pain.Reference reports: mw5145171, mw5145172.

• Brand Name: CORENTEC LOSPA SIZE 6-KNEE PROSTHESIS
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): CORENTEC CO., LTD.
• MDR Report Key: 17690094
• Report Number: MW5145170
• Device Sequence Number: 20268546
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2023
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "EPIDURAL STEROID INJECTION"; "NEUROLYTIC AGENT"; BONE CEMENT; IBUPROFEN
• Outcome Attributed to Adverse Event: Required Intervention; Disability; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White