MAUDE Adverse Event Report: EXACTECH, INC. LGC TIBIAL FIT TRAY CEM SZ 4F / 3T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-45-4030
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Deformity/ Disfigurement (2360); Osteolysis (2377); Joint Laxity (4526); Joint effusion (4849)
Date of Event	02/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 5888710 02-012-45-4030 - bandeja tibial logic fit 4f/3t.6195440 02-010-01-0240 - femur ps cem.Nº4 izq.
Event or Problem Description
It was reported that a patient, who had an initial knee implanted in (b)(6) 2020, underwent a revision procedure in (b)(6) 2024, approximately 4 years 10 months post the initial procedure.Pain, joint effusion and prosthetic instability with radiological findings of osteolysis in relation to the tibial and femoral components, pet wear and other tests with a diagnosis of aseptic loosening of the knee prosthesis.Elevated levels of metals (chromium and cobalt) in the blood.Prosthesis affected by health alert for its withdrawal from the market.Significant disability.Need for surgical intervention to avoid injury or permanent disability.Threat to life.X-ray images were provided.No device images were provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2025-00191 and 1038671-2025-00554.The revision reported may have been the result of a combination of prosthesis wear, loosening of the tibial and/or femoral components, and instability.Osteolysis and loosening may have led to an increase in cement and bone particles in the joint space and resulted in prosthesis wear, prosthesis wear may have contributed to particle-induced osteolysis, and instability may have contributed to the reported wear or have been the result of wear and loosening.However, the failures cannot be confirmed and contributions of loosening, prosthesis wear, and instability to the sequence of events cannot be determined as the devices were not available for evaluation and images and relevant clinical information were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: a2, a3, a4, b3, b5, b7, d6b, h6 clinical code the following sections were corrected: b3, b5 - "underwent a revision procedure in (b)(6) 2024, approximately 4 years 10 months post the initial procedure" no loner applies, d6b 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
Physical exam at symptom onset (b)(6): ambulates with antalgic gait.Subjective sensation of instability.Gross varus deformity.Tense joint effusion.Bone scan findings suggestive of aseptic loosening of the left total knee replacement.Intraoperative finding of massive polyethylene wear.Intraoperative pathology of the synovium showed granulomatous reaction to foreign body.Tibial metaphyseal osteolysis classified as aori 2b, complete rupture of the medial collateral ligament, medial femoral condyle defect classified as aori 2a.Reconstruction with rotational hinge prosthesis s-rom (competitor's device) with tibial metaphyseal sleeve patient suffered permanent disability as a direct result of this event.

• Brand Name: LGC TIBIAL FIT TRAY CEM SZ 4F / 3T
• 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: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 21270410
• Report Number: 1038671-2025-00555
• Device Sequence Number: 8157430
• Product Code: JWH
• UDI-Device Identifier: 10885862004017
• UDI-Public: 10885862004017
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K101981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/27/2025

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: 02-012-45-4030
• 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: 01/08/2025
• Supplement Date Received by Manufacturer: 03/04/2025; 05/05/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 03/05/2025; 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 95 KG