MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE+, SZ 6, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-48-6009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	08/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 8 years post op initial right tka, this 69 y/o male patient was revised due to poly wear.Everything was removed and replaced by competitors devices.No breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.No other patient information/medical history reported.Unable to obtain photos/x-rays.Product not returning - disposed at the hospital.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): femoral component cr, cemented size - 02-010-03-0360 - 3460195.Fit tibial tray cemented size 6f/5t - 02-012-45-6050 - 3680758.Three peg patella, 38mm - 200-02-38 - 3840256.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of prosthesis wear of the tibial insert and/or patella possibly due to malalignment between the implants, high contact stresses during knee flexion/extension, third body wear, patient-related conditions, instability, or any combination of these possibilities.The cause and extent of the prosthesis wear cannot be determined because minimal information was provided, the revised components were not returned for evaluation, and no radiographs or images were provided.Section h11: *the following sections have corrected information: (h6) component code: 734, bearings.
Additional Manufacturer Narrative
The revision reported was likely the result of prosthesis wear of the tibial insert and/or patella possibly due to malalignment between the implants, high contact stresses during knee flexion/extension, third body wear, patient-related conditions, instability, or any combination of these possibilities.The cause and extent of the prosthesis wear cannot be determined because minimal information was provided, the revised components were not returned for evaluation, and no radiographs or images were 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 CR TIB INSERT SLOPE+, SZ 6, 9MM
• 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17641357
• Report Number: 1038671-2023-02073
• Device Sequence Number: 5590813
• Product Code: JWH
• UDI-Device Identifier: 10885862174680
• UDI-Public: 10885862174680
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2025

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: 12/31/2022
• Device Catalogue Number: 02-012-48-6009
• 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: 08/08/2023
• Supplement Date Received by Manufacturer: 10/27/2023; 02/11/2025
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 12/19/2023; 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2015
• 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 H10.
• Patient Age: 69 YR
• Patient Sex: Male