MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE +. SZ 3.5, 9 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	SPECIFIC DEVICE NOT REPORTED
Medical Device Problem Codes	Fracture (1260); Unstable (1667); Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Joint Laxity (4526); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	07/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation the patient had a left knee replacement on (b)(6) 2016.Patient has stated pain for approximately 2 years.Patient stated that on doctor saw his left knee x-ray and confirmed a failed poly.Patient is scheduled for revision surgery on (b)(6) 2023.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Pending investigation.
Additional Manufacturer Narrative
H6: corrected the following: health effect - clinical code, impact code, problem code, component code, type of investigation, investigation findings, investigation conclusions g4: corrected.D4: corrected.H4: corrected.D10: (b)(6), 02-010-03-0235 - logic cr femoral cem, left, sz 3.5.(b)(6), 02-012-45-3535 - lgc tibial fit tray cem sz 3.5f / 3.5t.(b)(6), 02-012-48-3509 - logic cr tib insert slope +.Sz 3.5, 9 mm.(b)(6), 200-02-32 - three peg patella 32mm.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability and/or due to inclusion of the polyethylene in the packaging recall.Additionally, a contributing factor to the reported wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.
Event or Problem Description
It was reported approximately 83 months after left total knee arthroplasty a patient underwent a left knee revision procedure to address pain and swelling of the knee approximately one year prior to revision.Post operative evaluation indicated asymmetric polyethylene wear with near complete collapse of the medial compartment.A revision operative report was provided.Post operative diagnosis noted polyethylene wear of the left knee prosthesis and significant synovitis.Intraoperatively the surgeon observed prolific synovium without infection.Polyethylene debris was observed in synovial fluid around the joint.The insert was inspected and noted to be worn both medially and laterally.It was noted the polyethylene wear was quite extensive, but the polyethylene insert was not broken through.The locking mechanism was still intact.It was noted there was no evidence of metal-on-metal wear.They polyethylene insert was exchanged.The patient was awakened from iv sedation and transferred to a gurney and taken to recovery room.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The product associated with the reported event is within the scope of recall z-0021-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.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 3.5, 9 MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17377884
• Report Number: 1038671-2023-01748
• Device Sequence Number: 6384235
• Product Code: JWH
• UDI-Device Identifier: 10885862159281
• UDI-Public: 10885862159281
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2025

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: 08/16/2019
• Device Model Number: SPECIFIC DEVICE NOT REPORTED
• Device Catalogue Number: 02-012-48-3509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2023
• Supplement Date Received by Manufacturer: Not provided; 10/04/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 11/06/2024; 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2011
• 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: Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male