MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 4, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CR TIB INSERT SLOPE++, SZ 4, 13MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	02/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the 71 y/o male patient had an original exactech total knee replacement.The exactech knee confirmed by x-ray.The patient returned to surgeon's office complaining of pain, swelling, and instability of the left total knee.The polyethylene insert is a recalled liner showing wear on imaging.The patient was scheduled for a knee revision and possible poly exchange.The patient underwent a complete revision of their left total knee to competitor's revision tka implants.The exactech poly insert was worn, the exactech femoral component was loose and disengaged from the femur bone, and the exactech tibia component on x-ray showed loosening along the proximal medial and lateral side.All implants were removed.The patient left the or stable following the total revision of their left tka.There was no breakage of device.There was a 30-45 minutes surgical delay/prolongation with no adverse events as a result due to the surgeon anticipated doing a poly swap but due to the lysis and loose components a total revision was required, which took longer than the original anticipated plan of action.Patient was last known to be in stable condition following the event.Images and x-rays received.The devices are not available for evaluation due to the implants were sent to the lab and legal at the hospital.
Additional Manufacturer Narrative
Section d10: concomitant products.Logic cr femoral cem, left, sz 4 (cat# 02-010-03-0240 / serial# (b)(6)).Lgc tibial fit tray cem sz 4f / 4t (cat# 02-012-45-4040 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision was likely the result of the reported pain, which was caused by prosthesis wear or an insufficient bond between the femoral and tibial components and the bone, which led to aseptic (non-infected) loosening.The reason for the reported loosening cannot be confirmed as the devices were not returned for evaluation.Failure of the cement used to secure the femoral and tibial components to their respective bones, may have lead to loosening at the cement-implant interface; however, this cannot be confirmed.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, inclusion of the polyethylene in the packaging recall, or any combination of these possibilities.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 4, 13MM
• 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: michael crader
• MDR Report Key: 18904115
• Report Number: 1038671-2024-00506
• Device Sequence Number: 7839511
• Product Code: JWH
• UDI-Device Identifier: 10885862174536
• UDI-Public: 10885862174536
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/16/2020
• Device Model Number: LOGIC CR TIB INSERT SLOPE++, SZ 4, 13MM
• Device Catalogue Number: 02-012-49-4013
• 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: 02/14/2024
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2012
• 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: THREE PEG PATELLA 32MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 88 KG