MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	02-012-44-2511
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Aseptic loosening (4883)
Date of Event	09/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial right tka on (b)(6) 2018.The patient was revised due to wear and loosening and the tibial insert and baseplate were replaced.The patient was last known to be in stable condition following the event.No other patient information/medical history provided.
Additional Manufacturer Narrative
Pending investigation.Concomitant medical devices: 02-012-41-2525 - logic tibia traptray cem sz 2.5f/2.5t 4509768, 02-020-11-0325 - truliant ps cem fem ps cem right sz 2.5 5679357, 200-02-35 - three peg patella 35mm 5393556.(b)(4).
Additional Manufacturer Narrative
H3: the revision reported was likely the result of prosthesis wear, osteolysis, and an insufficient bond between the tibial component and the bone, which led to aseptic (non-infected) tibial 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.Additionally, a contributing factor to the wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.The extent and root cause of the prosthesis wear, osteolysis, and tibial loosening could not be determined as the devices were not returned for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d8, f6, f9 (remove erroneous dates from initial report) h6: clinical code, component code, investigation findings, investigation conclusions, h10.H10: multiple mdr reports were filed for this event, please see associated report: 1038671-2026-00293.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
Report #1 of 2 for this event.As reported, the patient had an initial right total knee arthroplasty.Subsequently, three (3) years, ten (10) months later, the patient underwent a right knee revision of the tibial components.The patient was last known to be in stable condition following the event.Images of the explants were provided and pre-operative radiographs were provided.No additional clinical information was provided.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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: ashley harris ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15623874
• Report Number: 1038671-2022-01311
• Device Sequence Number: 6498845
• Product Code: JWH
• UDI-Device Identifier: 10885862173522
• UDI-Public: 10885862173522
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2026

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: 01/29/2021
• Device Model Number: 02-012-44-2511
• Device Catalogue Number: 02-012-44-2511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/30/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2022
• Supplement Date Received by Manufacturer: 02/08/2024; 03/11/2026
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 02/23/2024; 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2013
• 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 H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male