MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 2, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	02-012-49-2013
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Distress (2329); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: logic cr femoral left sz 2 02-010-03-0220 5156462 logic tibial fit tray cemented sz 2f/2t 02-012-45-2020 5259032 three peg patella 26mm 200-02-26 5020410 h7: z-0021-2022.
Event or Problem Description
As reported, the patient had an initial left tka on (b)(6) 2018.The patient presented back to the surgeons office with complaints of pain, swelling, instability, and dissatisfaction with their left tka.The patient has a recalled implant.The patient underwent a left tka tibial poly swap and patella implant swap on (b)(6) 2023.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history provided.
Additional Manufacturer Narrative
H11.Updated/additional information ¿ b5.D8.G1.G2.G4.H6.The revision reported was likely the result of patella wear, prosthesis wear secondary to increased loading of the posterior aspect of the tibial insert, and instability, which may have contributed to the patient¿s pain and swelling.
Event or Problem Description
This patient is verified left knee on (b)(6) 2018 /she had left knee revision (b)(6) 2023 revision operative report of (b)(6) 2023 - postoperative diagnosis: 1.Failed polyethylene tibial component, left knee 2.Failed polyethylene patellar component.Patient was revised to exactech devices.Patient presented with pain and swelling.No evidence of infection.No radiographic demonstration of osteolysis.The polyethylene showed posterior, medial and lateral delamination.No loosening of the tibial or femoral components.Significant delamination of the patellar polyethylene component, without loosening.The patient was transferred to pacu in stable condition, there were no intraoperative complications identified.(op report attached).
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported in was likely the result of patella wear, prosthesis wear secondary to increased loading of the posterior aspect of the tibial insert, and instability, which may have contributed to the patient¿s pain and swelling.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 2, 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16766261
• Report Number: 1038671-2023-00741
• Device Sequence Number: 6671108
• Product Code: JWH
• UDI-Device Identifier: 10885862174338
• UDI-Public: 10885862174338
• 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: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2025

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: 04/15/2021
• Device Model Number: 02-012-49-2013
• Device Catalogue Number: 02-012-49-2013
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/29/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2023
• Supplement Date Received by Manufacturer: 05/15/2024; 01/22/2025
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 06/10/2024; 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2015
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female