MAUDE Adverse Event Report: EXACTECH, INC. LGC TIBIAL FIT TRAY CEM SZ 2.5F / 1.5T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-45-2515
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	08/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6) 02-012-49-2509 - logic tibial insert slope ++, sz 2.5, 9 mm.(b)(6) 02-010-04-0225 - logic cr femoral por, left, sz 2.5.(b)(6) 200-02-32 - three peg patella 32mm.(b)(6) 201-78-15 - holding pin mini sharp point 4 pk.(b)(6) 201-78-81 - 3 trocar, mod.Hex 2pk.(b)(6) 521-78-23 - threaded pin size 2.3 collared.(b)(6) 521-78-23 - threaded pin size 2.3 collared.(b)(6) 521-78-32 - threaded pin size 3.0 collarless.(b)(6) a10012 - gps implant kit v2.(b)(6) stk190-119-90 - stryker saw blade.G2: australia.H10: multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-02218, 1038671-2025-03644.The revision reported was likely the result of prosthesis wear, prosthesis fracture, and insufficient bonds between the implants and the bones, which resulted in aseptic (non-infected) loosening.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the prosthesis wear, prosthesis fracture, and loosening could not be determined as the devices were not returned for evaluation, 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, approximately 7 years post op initial left total knee arthroplasty, this was revised due to poly wear and femoral and tibial components aseptic loosening.All components were replaced with a revision knee system.Patient was last known to be in stable condition following the event.No further patient impact was reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6: types of investigation and investigation findings.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 2.5F / 1.5T
• 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 23921667
• Report Number: 1038671-2025-03645
• Device Sequence Number: 9041254
• Product Code: JWH
• UDI-Device Identifier: 10885862003928
• UDI-Public: 10885862003928
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2025

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 Expiration Date: 06/24/2025
• Device Catalogue Number: 02-012-45-2515
• 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: 08/18/2023
• Supplement Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female