MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 3.5, 11 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-47-3511
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6) 200-02-35 - three peg patella 35mm.(b)(6) 02-010-04-0335 - logic cr femoral por, right, sz 3.5.(b)(6) 02-012-45-3535 - lgc tibial fit tray cem sz 3.5f / 3.5t.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that a male patient, who had an initial right knee implanted, underwent a revision procedure approximately 9 years 8 months post the initial procedure.The patient was revised due to a suspected infection.All devices were removed.There were no surgical delays or device breakages reported.The patient was last known to be in stable condition following the event.No x-rays were able to be obtained.The explanted devices are not available for return.The hospital disposed of them.Device images were provided.Prosthesis wear was observed on the explanted liner image.No further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6, h11.The following sections were corrected: d1, h6.No device was returned for evaluation; photographs of the device were provided; however, the reported event was unable to be confirmed.The review identified that the articular surface of the tibial insert appears to have minor pitting and wear on the articular surface.The yellowish stained surface is consistent with subsurface damage and there appears to be a minor area of delamination.The wear on the medial side and lateral side appears consistent with bone or cement overhang from the sides of the femoral component.The explanted femoral component and tibial tray show residual bone cement and biological material adhering to the bone contacting surfaces of these components.Operative notes and/or medical records were not provided for review of usage/ technique.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, may have resulted from the reported infection or due to the inclusion of the polyethylene in the packaging recall.The prosthesis wear appears minor and was likely not the root cause of the revision.The cause for the infection could not be confirmed from the provided information.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC CR TIB INSERT STD, SZ 3.5, 11 MM
• 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: 22669893
• Report Number: 1038671-2025-02642
• Device Sequence Number: 7767757
• Product Code: JWH
• UDI-Device Identifier: 10885862159250
• UDI-Public: 10885862159250
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2025

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: 06/06/2022
• Device Catalogue Number: 02-012-47-3511
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2014
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male