MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 2.5 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC TIBIA PS MOD INSRT SZ 2.5 15MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Osteolysis (2377); Implant Pain (4561)
Date of Event	02/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product associated with the reported event is within the scope of recall z-0021-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.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
Legal case ¿ usa patient id: (b)(6).On (b)(6) 2024, (b)(6), rn- additional information from legal 6 feb 2024.Revision operative report of (b)(6) 2021- operation: revision of right total knee arthroplasty of femoral component and tibial polyethylene exchange.Postoperative diagnosis: failed right total knee with loose femoral component and severe osteolysis.Operative findings: there was found to be a clean wound with a copious amount of clear synovial fluid and an abundance of extraneous synovial tissue.A complete synovectomy was then performed.There was a grossly loose femoral component with moderate osteolysis of the medial femoral condyle, requiring augmentation on the revision component.There was a well-fixed tibial component, as well as patellar component."there was a moderate amount of osteolysis of the polyethylene component." the patient was awakened and transferred to recovery in stable condition.There were no complications.Product: optetrak logic femoral component (02-010-01-0325, sn (b)(6).Concomitants tibia tray (02-012-45-2525, sn (b)(6) / tibial insert (02-012-35-2515, sn (b)(6) / stem extn fluted knee (204-34-02, (b)(6) / extension screw stem tibial (204-70-00, (b)(6) / patella 3peg (200-02-32, (b)(6) / stryker simplex cement.It was reported via legal documentation the patient had a right knee replacement on (b)(6)2013.Approximately 7 years and 7 months after the initial procedure the patient had a right knee revision on (b)(6) 2021.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.Unable to locate patient in ebi.Historical record and smartsolve searched for sn/patient name with no results.
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.
Event or Problem Description
It was reported that approximately 92 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, failure of implant, implant pain, osteolysis, and synovitis.Initial surgery and revision surgery operative notes were provided.Patient left the operating room in stable condition.No further issues or complications were reported.No additional information is available.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 2.5 15MM
• 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: 21211326
• Report Number: 1038671-2025-00344
• Device Sequence Number: 11741417
• Product Code: JWH
• UDI-Device Identifier: 10885862001795
• UDI-Public: 10885862001795
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• 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): 03/12/2025

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: 09/21/2015
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 2.5 15MM
• Device Catalogue Number: 02-012-35-2515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/08/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2023
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2010
• 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 Sex: Unknown