MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 13MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932); Synovitis (2094); Osteolysis (2377); Implant Pain (4561); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.D10 concomitants: patella three peg 38 mm (200-02-38, (b)(6), femoral logic ps cem sz 4 (02-010-01-0340, (b)(6), tray tibia logic cem sz 4f/4t (02-012-41-4040, (b)(6), insert tibia logic psc 4 13 mm (02-012-44-4013, (b)(6).
Event or Problem Description
Legal case: (b)(4).Refer to (b)(4).Summary of original description as reported: as reported via legal documentation, this patient was initially implanted on (b)(6) 2015 with an unspecified optetrak logic device.The device was explanted on (b)(6) 2019, approximately 4 years 9 months after their initial procedure due to joint pain, joint swelling and stiffness, tissue damage, loosening, and 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.No device return anticipated due to this being a legal case.Ebi initial surgery not found.Historical record & smartsolve searched for sn/patient name with no results.No further information.Updated information received from legal 08/01/2023: as reported via legal documentation, this patient was initially implanted on (b)(6) 2015 due to arthritis.The device was explanted on (b)(6) 2019, approximately 4 years 9 months after their initial procedure due to joint pain.Revision op report postoperative diagnosis: aseptic loosening of the right total knee prosthesis femoral component.The surgeon noted that the femoral component demonstrated complete loss of fixation to the bone and was manually extracted from the joint.Inspection revealed an apparent debonding of the femoral component at the cement/component interface.Further inspection of the femur revealed extensive pseudomembrane formation over the entire cement mantle.Extensive bone loss was noted in various areas of the femoral condyles but most pronounced in the posterior condyles both medially and laterally.The patella was also inspected and demonstrated minimal wear and no evidence of gross loosening.Findings: gross loosening of femoral component with aggressive inflammatory response and erosion of femoral condyles.Impingement wear of post on tibial polyethylene insert.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Event or Problem Description
"legal case ¿ usa patient id: + left knee it was reported via legal documentation that approximately 58 months after a left total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, joint pain, joint swelling, stiffness, tissue damage, loosening, osteolysis.Initial surgery and revision surgery operative notes were provided.Patient left the operating room in stable condition.Post operative diagnosis noted wear of the implant.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
B4: corrected.
Event or Problem Description
It was reported via legal documentation that approximately 58 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, failure of implant, implant pain, inflammation, osteolysis, swelling/edema, and synovitis.Revision surgery operative notes were provided.Patient left the operating room in stable condition.Post operative diagnosis noted wear of the implant.No further issues or complications were reported.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 IMPLANT PSC INSERT, SZ 4, 13MM
• 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: 21143755
• Report Number: 1038671-2025-00214
• Device Sequence Number: 15727591
• Product Code: JWH
• UDI-Device Identifier: 10885862173652
• UDI-Public: 10885862173652
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/11/2025

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 Expiration Date: 05/29/2022
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 13MM
• Device Catalogue Number: 02-012-44-4013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/01/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2023
• Supplement Date Received by Manufacturer: 01/31/2025; 03/11/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 01/31/2025; 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2014
• 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: 57 YR
• Patient Sex: Male