MAUDE Adverse Event Report: EXACTECH, INC. LOGIC PTS, SIZE 3, 8MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC PTS, SIZE 3, 8MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Joint Laxity (4526); Swelling/ Edema (4577); Medical device site infection (4845)
Date of Event	07/05/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by legal brief, on (b)(6) 2013, patient underwent a left total knee arthroplasty (tka).Eventually, patient began to suffer from increasing pain, swelling, and instability in her left knee, which subsequently became infected.On (b)(6) 2017, patient underwent revision of her left optetrak device.Upon explanation of the optetrak device, patient¿s surgeon observed that there were signs of metal-wear debris, as well as evidence of micromotion between the metal augment and the tibial tray.The operative surgeon stated his belief that ¿this was the cause¿ of the infection that necessitated revision.No additional information.
Additional Manufacturer Narrative
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.D10 concomitants: 02-012-44-3011 - logic tibia implant psc insert, sz 3, 11mm, (b)(6), 02-010-01-0230 - logic femoral ps cem left sz 3, (b)(6), 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t, (b)(6) , 200-02-35 - three peg patella 35mm, (b)(6), (b)(6) - gps knee implant kit, 05 0310 13 020.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, d, g.The reason for the revision reported cannot be confirmed from the information provided but may be the result of infection and prosthesis wear or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC PTS, SIZE 3, 8MM
• 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: 21401721
• Report Number: 1038671-2025-01018
• Device Sequence Number: 12892580
• Product Code: JWH
• UDI-Device Identifier: 10885862003386
• UDI-Public: 10885862003386
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K071738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• 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): 06/19/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/06/2023
• Device Model Number: LOGIC PTS, SIZE 3, 8MM
• Device Catalogue Number: 02-012-42-3008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/16/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 06/19/2025
• Date Device Manufactured: 06/07/2013
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female