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

Catalog Number	02-012-47-4009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 02-010-03-0240 - logic cr femoral cem, left, sz 4 (b)(6) 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t (b)(6) 200-02-38 - three peg patella 38mm (b)(6) 204-32-01 - fluted stem extension 11l x 12 mm (b)(6) 204-70-00 - tibial stem ext.Screw (b)(6).The complaint device, (tibial insert), was evaluated, and the reported event was not confirmed.The evaluation identified third body wear which occurs when a third body, such as a fragment of bone or bonce cement, gets trapped between the articulating surfaces of the insert and the femoral component.There was little to no motion between the tibial insert and the tibial tray indicated.A review of complaint history determined that no further action is required as no trends were identified.The reason for the revision reported in cannot be confirmed from the reported information but may be related to prosthesis wear (as seen on the returned insert), instability, and/or bone quality.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that a patient, who had an initial left knee implanted, date unknown, was successfully revised to a logic cc knee.The patient's liner is suspected to be part of the recall.Multiple request for information were sent, no information has been provided.This is 1 of 2 reports for this incident.

• Brand Name: OPTETRAK LOGIC
• 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; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 24867495
• Report Number: 1038671-2026-00417
• Device Sequence Number: 10019518
• Product Code: JWH
• UDI-Device Identifier: 10885862174444
• UDI-Public: 10885862174444
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/13/2026

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: 12/20/2025
• Device Catalogue Number: 02-012-47-4009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2017
• Is the Device Labeled for Single Use? (Y/N): No
• 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; Hospitalization
• Patient Sex: Male