MAUDE Adverse Event Report: EXACTECH, INC. LOGIC; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	CC TIBIAL INSERT SZ 3, 9MM
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Failure of Implant (1924); Pain (1994); Synovitis (2094); Osteolysis (2377); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Aseptic loosening (4883)
Date of Event	04/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined, insufficient information.
Event or Problem Description
It was reported via a legal notification, that a 71 yo male patient, initial right knee implanted on (b)(6) 2009 with polyethylene tibial lining manufactured by exactech, inc, suffered personal injuries from that surgery, including but not limited to bone loss and the need for further surgery.No additional information.
Additional Manufacturer Narrative
D10.Concomitants: tray, tibia trapezoid cementedsize3f/3t, cat# 204-04-33, sn (b)(6); patella, three peg 35mm, cat# 200-02-35, sn (b)(6); extension, femoral andtibialflutedstem 12mm od x11mm l, cat# 204-32-01, sn (b)(6).Component, femur non¿modular cck size 3, cat#210-01-03, sn (b)(6).H3: investigation results - the revision reported was likely the result of wear of the tibial insert and suspected aseptic (non-infected) loosening.The cause and extent of the prosthesis wear cannot be determined because the revised components were not returned for evaluation and no x-rays or photographs were provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b3, b5, g1, g2, h6- health effect - clinical code, component code, type of investigation, investigation findings, h7 and h11.The revision reported was likely the result of wear of the tibial insert and suspected aseptic (non-infected) loosening.The cause and extent of the prosthesis wear cannot be determined because the revised components were not returned for evaluation and no x-rays or photographs were provided.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 the patient underwent an initial right total knee arthroplasty.Subsequently, it was reported that the patient experienced pain, swelling, osteolysis and prosthesis wear.As a result, the patient underwent a right knee revision approximately 13 years after initial implantation.Patient was last known to be in stable condition.No further information available.

• Brand Name: LOGIC
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15718528
• Report Number: 1038671-2022-01395
• Device Sequence Number: 4897337
• Product Code: JWH
• UDI-Device Identifier: 10885862054241
• UDI-Public: 10885862054241
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• 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): 03/24/2026

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: 01/26/2014
• Device Model Number: CC TIBIAL INSERT SZ 3, 9MM
• Device Catalogue Number: 208-23-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2022
• Supplement Date Received by Manufacturer: 12/27/2023; 03/16/2026
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 01/03/2024; 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2009
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0019-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male