MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA TRAPTRAY CEM SZ 3F/3T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC TIBIA TRAPTRAY CEM SZ 3F/3T
Medical Device Problem Codes	Mechanical Problem (1384); Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Arthralgia (2355); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	10/03/2022
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
(b)(4); 6 dec 2023, (b)(6), rn ¿ additional information received from legal on (b)(6) 2023/ revision operative report of (b)(6) 2022- revised to competitor¿s devices.Post-op diagnosis: aseptic failure of left total knee arthroplasty.The patient was having pain, significant osteolysis and suspected loosening.Significant osteolysis was noted under the anterior femoral flange.The polyethylene liner was removed easily.The femoral implant was debonded from the cement.Significant osteolysis was noted behind the cement after it was removed both anteriorly as well as in the metaphyseal region of the femur affecting both the medial and lateral femoral condyles, especially posteriorly in the lateral femoral condyle.The tibial implant was debonded from the cement.There was noted to be defects through the tibial metaphysis posteriorly and laterally.The patient was released from the operating room table, transferred to the hospital bed and taken to recovery room in stable condition.Revision operative report attached.Optetrak logic psc tibial insert size 3, 11 mm (2095307) optetrak logic posterior stabilized cemented femoral component size 3 optetrak logic trapezoid cemented tibial tray size 3f/3t optetrak 3-peg patella 35mm no device return anticipated due to this being a legal case.Unable to locate surgeon/patient/serial number in ebi.No serial numbers available.Original description summary as reported via legal documentation the patient had a left knee replacement on (b)(6) 2011.Approximately 11 years after the initial procedure the patient had a left knee revision on (b)(6) 2022 due to joint pain, joint swelling and stiffness, limited range of motion, loss of mobility, tissue damage, revision surgery, instability, loosening, polyethylene wear, osteolysis.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.Ebi initial surgery could not be located.Historical record & smartsolve searched for patient name with no results.
Event or Problem Description
As reported via legal documentation the patient had a left knee replacement on (b)(6) 2011.Approximately 11 years after the initial procedure the patient had a left knee revision on (b)(6) 2022 due to joint pain, joint swelling and stiffness, limited range of motion, loss of mobility, tissue damage, revision surgery, instability, loosening, polyethylene wear, osteolysis.There is no other patient demographic or medical history available.There is no information on the surgical procedure or 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
This follow-up report is being submitted to relay corrected information.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIBIA TRAPTRAY 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 20907573
• Report Number: 1038671-2024-04773
• Device Sequence Number: 9155665
• Product Code: JWH
• UDI-Device Identifier: 10885862003171
• UDI-Public: 10885862003171
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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 Model Number: LOGIC TIBIA TRAPTRAY CEM SZ 3F/3T
• Device Catalogue Number: 02-012-41-3030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/26/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 03/19/2025
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male