MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 2.5, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-51-2513
Medical Device Problem Codes	Naturally Worn (2988); Lack of Effect (4065)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 73 yo male patient, who had a left tka, underwent a revision procedure approximately 7 years 2 months post the initial procedure.The patient presented back to the surgeon¿s office with complaints of stiffness, pain, and dissatisfaction with their left total knee.Additional information provided indicated the patient had a loss of range of motion.The patient was scheduled for a revision left tka possible polyethylene swap and subsequently underwent a tibial poly implant swap and patella implant swap.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.X-ray images were provided.The explanted devices are not available for return as they were discarded by the hospital.No images of the explanted devices were provided.No further information available.
Additional Manufacturer Narrative
D10: 02-010-03-0225 - logic cr femoral cem, left sz 2.5:(b)(6), 02-012-45-2535 - lgc tibial fit tray cem sz 2.5f / 3.5t: (b)(6), 200-02-32 - three peg patella 32mm: (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

• Brand Name: LOGIC TIB INSERT IMPL CRC, SZ 2.5, 13MM
• 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 66th ct; gainesville, FL 32653
• MDR Report Key: 23918050
• Report Number: 1038671-2025-03643
• Device Sequence Number: 21315281
• Product Code: JWH
• UDI-Device Identifier: 10885862230386
• UDI-Public: 10885862230386
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• 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): 12/29/2025

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
• Device Catalogue Number: 02-012-51-2513
• 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: 12/08/2025
• Initial Report FDA Received Date: 12/29/2025
• 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; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male