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

Catalog Number	02-012-45-2525
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Synovitis (2094); Osteolysis (2377); Joint effusion (4849)
Date of Event	06/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6) - 02-010-03-0325 - logic cr femoral cem, right, sz 2.5 (b)(6) 200-02-35 - three peg patella 35mm (b)(6) 02-012-47-2509 logic cr tib insert std, sz 2.5, 9 mm.Multiple mdr reports were filed for this event, please see associated report: 1038671-2024-03210.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.
Event or Problem Description
It was reported that approximately 75 months after a right knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear and extensive osteolysis.Post operative diagnosis noted mechanical failure of right total knee replacement.Post operative findings noted complete medial polyethylene wear with fractured polyethylene.Intraoperatively the surgeon observed moderate effusion, medial and tibial osteolysis extending to the stem of the prosthesis and the entirety of the medial aspect of the femur.It was also noted there was synovitis consistent with poly wear extensively throughout the knee.Upon removing the tibia, the surgeon observed a fracture through the osteolysis of the posterior medial plateau.The posterior medial void was filled with cement and had additional fixation of the remaining fracture fragments.No medical or surgical interventions were reported.No additional information is available.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, fracture, bone fracture 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.G4: corrected.H6: corrected.Component and investigation clinical codes.

• Brand Name: LGC TIBIAL FIT TRAY CEM SZ 2.5F / 2.5T
• 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
• MDR Report Key: 21150899
• Report Number: 1038671-2025-00247
• Device Sequence Number: 15750554
• Product Code: JWH
• UDI-Device Identifier: 10885862003935
• UDI-Public: 10885862003935
• 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: 2017
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2025

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 Catalogue Number: 02-012-45-2525
• 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: 01/25/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 01/17/2025
• Date Device Manufactured: 02/01/2017
• 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 H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female