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

Catalog Number	02-012-35-2511
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	10/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 02-010-01-0325 - femur ps cem.Nº2.5 der.: 5213253.02-012-45-2515 - bandeja tibial logic fit 2.5f/1.5t: 5452246.200-02-32 - rotula tres tetones 32 mm: 5771922.204-34-04 - vastago ext.14 x 40 mm: 5705864.204-70-00 - tornillo fijacion vástago a tibia: 5756547.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 a female patient, who had tkas in both knees, underwent a revision procedure on the right knee.It was indicated that the prosthesis is on the recall list.It was also indicated a future revision is scheduled for the left knee.The patient was last known to be in stable condition following the event.No further information.This is 1 of 2 events for this patient.
Event or Problem Description
Patient underwent revision procedures on boht knees.Both knees began to fail and have swelling and pain.The patient indicated the explanted devices were clearly at fault due to the particles of the polyethylene dissolving the bones.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h3, h6, h11 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.A review of complaint history determined that no further action is required as no trends were identified.The reason for the reported revision cannot be confirmed from the information provided but may be the result of prosthesis wear or due to inclusion of the polyethylene in the packaging recall.However, the reported prosthesis wear cannot be confirmed and potential contributions of user, or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images radiographs, or relevant clinical information were provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: LOGIC KNEE COMPONENTS
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 23968427
• Report Number: 1038671-2026-00010
• Device Sequence Number: 9249993
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2026

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: 08/04/2025
• Device Catalogue Number: 02-012-35-2511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 04/13/2026; 03/23/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 05/04/2026; 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2017
• 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: Required Intervention
• Patient Sex: Female