MAUDE Adverse Event Report: EXACTECH, INC. LGC TIBIAL FIT TRAY CEM SZ 2F / 2T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-45-2020
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Osteolysis (2377); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that approximately 36 months after a right total knee replacement procedure, the patient underwent a revision procedure to address loosening.Revision surgery operative notes were provided.Post operative findings noted significantly loose patella and tibial components with bone loss medially and a fractured polyethylene anteromedially and posterolaterally.Intraoperatively it was noted the femur demonstrated it did not appear to be loose.No surgical or medical interventions were reported.No additional information is available.
Additional Manufacturer Narrative
D10: (b)(6) 02-020-13-0320 - truliant cr cem fem cr cem right sz 2.(b)(6) 02-022-47-2009 - truliant tib imp cr ins std sz 2, 9mm.(b)(6) 204-32-01 - fluted stem extension 11l x 12 mm.(b)(6) 204-70-00 - tibial stem ext.Screw.(b)(6) 200-02-35 - three peg patella 35mm.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2022-01121.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, fracture, tibial loosening, and patellar loosening.Or due to inclusion of the polyethylene in the packaging recall.Additionally, a contributing factor to the reported wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.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.

• Brand Name: LGC TIBIAL FIT TRAY CEM SZ 2F / 2T
• 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 ; 3523771140
• MDR Report Key: 21577334
• Report Number: 1038671-2025-01550
• Device Sequence Number: 8940006
• Product Code: JWH
• UDI-Device Identifier: 10885862003904
• UDI-Public: 10885862003904
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K101981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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 Catalogue Number: 02-012-45-2020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 03/31/2025
• Date Device Manufactured: 03/05/2019
• 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: Required Intervention; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Female