MAUDE Adverse Event Report: EXACTECH, INC. LGC TIBIAL FIT TRAY CEM SZ 3F / 3T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-45-3030
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Joint Laxity (4526); Swelling/ Edema (4577); Medical device site infection (4845)
Date of Event	07/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report number: 1038671-2022-01555 d10 concomitants: 02-010-01-0230 - logic femoral ps cem left sz 3 2766483 02-012-42-3008 - logic pts, size 3, 8mm 1918766, 2706824, 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t 2819503 200-02-35 - three peg patella 35mm 2700643 a10007 - gps knee implant kit 05 0310 13 020 multiple mdr reports were filed for this event, please see associated reports: 1038671-2022-01555 the reason for the revision reported cannot be confirmed from the information provided but may be the result of infection and prosthesis wear or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
As reported via legal documentation, a patient had left tka on 16 dec 2013 due to severe osteoarthritis, rheumatoid arthritis.They subsequently underwent left tka revision surgery on 05 jul 2017, approximately 3 years 7 months after their initial implantation.In the years following the surgeries, the patient experienced pain, swelling, instability, and bone loss on both knees caused by early and accelerated polyethylene wear and/or component loosening.Ultimately, on july 5, 2017, plaintiff underwent an extensive revision surgery on her left knee.05 jul 2017 op report: one-stage revision infected left total knee with removal of all infected components, radical debridement synovectomy, and placement of in-growth knee construct.Report states that there was yellow appearing purulent material in the joint and there were also signs of metal-wear debris with dark-stained synovial tissue, as well as evidence of micromotion between the metal augment and the tibial tray.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.

• Brand Name: LGC TIBIAL FIT TRAY CEM SZ 3F / 3T
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 21263476
• Report Number: 1038671-2025-00520
• Device Sequence Number: 13114907
• Product Code: JWH
• UDI-Device Identifier: 10885862003966
• UDI-Public: 10885862003966
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/08/2023
• Device Catalogue Number: 02-012-45-3030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 01/29/2025
• Date Device Manufactured: 10/11/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female