MAUDE Adverse Event Report: EXACTECH, INC. LGC TIBIAL FIT TRAY CEM SZ 3F / 2T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-45-3020
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Unspecified Tissue Injury (4559)
Date of Event	09/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The revision reported may have been the result of polyethylene wear, osteolysis and tibial loosening.The aseptic (non-infected) tibial loosening was likely the result of an insufficient bond between the tibial tray and the bone and patient-related conditions.However, this cannot be confirmed as the devices were not returned for evaluation.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 reported polyethylene wear and osteolysis cannot be determined as the devices were not available for evaluation and pre-revision radiographs and images of the explanted devices were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.D10: 02-010-01-0330 - logic femoral ps cem right sz 3 2625341, 02-012-35-3015 - logic tibia ps mod insrt sz 3 15mm 1764727, 13a2101 - cemex system fast genta 70g aa6828, 200-02-32 - three peg patella 32mm 2725158.
Event or Problem Description
It was reported that the patient underwent an initial right total knee arthroplasty.Subsequently, the patient experienced pain, ambulation difficulties, instability, tibial loosening and wear of the tibial insert.As a result, the patient underwent a right knee revision approximately 7 years and 2 months after initial implantation.The patient was last known to be in stable condition.No additional information available.

• Brand Name: LGC TIBIAL FIT TRAY CEM SZ 3F / 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 66 court; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 24520053
• Report Number: 1038671-2026-00227
• Device Sequence Number: 18564949
• Product Code: JWH
• UDI-Device Identifier: 10885862003959
• UDI-Public: 10885862003959
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/05/2026

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: 05/28/2018
• Device Catalogue Number: 02-012-45-3020
• 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: 09/13/2022
• Initial Report FDA Received Date: 03/05/2026
• Date Device Manufactured: 05/28/2010
• 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: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female