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

Catalog Number	02-012-45-3030
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Aseptic loosening (4883)
Date of Event	07/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10.Related: mfr #1038671-2023-01283 report 1 of 4.Mfr # 1038671-2024-02196 report 2 of 4.Mfr #1038671-2024-02201 report 3 of 4.Additional manufacturer narrative- report 4 of 4.D10.Concomitants: (b)(6), 204-70-00 - tibial stem ext.Screw; (b)(6), 02-010-03-0230 - logic cr femoral cem, left, sz 3; (b)(6), 204-34-04 - fluted stem extension 40l x 14 mm; (b)(6), 200-02-35 - three peg patella 35mm; (b)(6), 02-012-51-3009 - logic tib insert impl crc, sz 3, 9mm.H3.The revision captured was likely the result of prosthesis wear and insufficient bonds between the components and the bones, which led to 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 and loosening could not be determined as the devices were not returned for evaluation, and images and radiographs were not provided.The risk documents were reviewed, and the risk is captured.A review of the dhr for the tibial tray was conducted.A complaint occurrence rate shows that this event is "very low".These devices are used for treatment not diagnosis.There is no additional information available.
Event or Problem Description
It was reported via legal documentation that a patient had a left total knee arthroplasty and then approximately 4 years, 8 months later was revised.Patient claims revision surgery for issues including but not limited to polyethylene wear, instability, and component loosening.There is no other patient demographic or medical history available.Revision op report postoperative diagnosis: painful and loose left total knee.¿the femur, tibia and patella components were found to be completely loose.¿ the patient's bmi and body morphology made the revision case more difficult.There is incomplete information on the surgical procedure without patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
H11:.Additional manufacturer narrative: additional information added.No additional information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b3, d1, e1, e2, e3, h6 - health effect - clinical code, type of investigation, investigation conclusion and h11.H10: multiple mdr reports were filed for this event, please see associated report: 1038671-2023-01283, 1038671-2024-02196, 1038671-2024-02201.The revision captured was likely the result of prosthesis wear and insufficient bonds between the components and the bones, which led to 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 and loosening could not be determined as the devices were not returned for evaluation, and images 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.

• Brand Name: LGC TIBIAL FIT TRAY CEM SZ 3F / 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 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19630363
• Report Number: 1038671-2024-02205
• Device Sequence Number: 12535852
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2026

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 Catalogue Number: 02-012-45-3030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 07/09/2024; 04/02/2026
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 07/18/2024; 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2017
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female