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

Model Number	LGC TIBIAL FIT TRAY CEM SZ 2F / 2T
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	09/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 6 yrs popstop the initial l tka, this female patient¿s left knee was revised due to poly wear and osteolysis.The insert was removed, the femur and tibia both checked and found to be loose.Patient had significant bone loss and needed a distal femoral replacement.Patient was last known to be in stable condition following the event.The device is not available for evaluation as the hospital discarded the devices.
Additional Manufacturer Narrative
The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.D10 concomitant products: (b)(6) - 02-012-44-2015 - logic tibia implant psc insert, sz 2, 15mm; (b)(6) - 02-010-01-0220 - logic femoral ps cem left sz 2; (b)(6) - 200-02-29 - three peg patella 29mm; (b)(6) - 201-78-82 - collar fixation pin 2pk 40mm, quick release; (b)(6) - 201-78-89 - 3" drill bit, mod.Hex 2 pack.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b.The revision reported was likely the result of a combination of prosthesis wear and femoral loosening.Additional reasons for the reported revision may be tibial loosening and inclusion of the polyethylene in the packaging recall.However, the reported tibial loosening could not be confirmed from the provided information.The prosthesis wear was likely due to excessive loading of the femoral component on the anterior portion of the tibial insert and third body wear.The loosening and osteolysis were likely the result of an insufficient bond between the implants and the bones and patient-related conditions.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation.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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21549840
• Report Number: 1038671-2025-01480
• Device Sequence Number: 4475277
• Product Code: JWH
• UDI-Device Identifier: 10885862003904
• UDI-Public: 10885862003904
• 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: 2015
• Device Explanted Year: 2021
• 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): 03/17/2025

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: 02/10/2024
• Device Model Number: LGC TIBIAL FIT TRAY CEM SZ 2F / 2T
• Device Catalogue Number: 02-012-45-2020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 03/17/2025
• Date Device Manufactured: 02/11/2014
• 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 Sex: Female