MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 9MM
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	01/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately nine years post initial left side tka, the 63 y/o female patient was brought back for left knee instability.Patient wad revised to a truliant size 3 15mm psc insert.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Photos and x-rays received.The device will be return.No other patient information/medical history reported.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.As reported, approximately nine years post initial left side tka, the 63 y/o female patient was brought back for left knee instability.Patient was revised to a truliant size 3 15mm psc insert.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Photos and x-rays received.The device will be return.No other patient information/medical history reported.Serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.The optetrak device with serial number 2947854 is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient¿s knee instability and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.The patient has lupus which is a cause of ligament and joint maladies.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, d8, h6 clinical code, device problem code, component code, investigation conclusion codes.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 9MM
• 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16386539
• Report Number: 1038671-2023-00175
• Device Sequence Number: 14879537
• Product Code: JWH
• UDI-Device Identifier: 10885862173553
• UDI-Public: 10885862173553
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/09/2025

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: 02/03/2022
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 9MM
• Device Catalogue Number: 02-012-44-3009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2023
• Supplement Date Received by Manufacturer: 06/12/2023; 10/09/2025
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 07/11/2023; 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2014
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LGC TIBIAL FIT TRAY CEM SZ 3F / 2T.; LOGIC FEMORAL PS CEM LEFT SZ 3.; THREE PEG PATELLA 35MM.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female