MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 4, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-51-4015
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); Osteolysis (2377); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	10/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant products 4398699 02-010-03-0340 - logic cr femoral cem, right, sz 4 6084624 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t 2652742 02-012-51-4015 - logic tib insert impl crc, sz 4, 15mm 6385401 200-02-32 - three peg patella 32mm recall: z-0021-2022.
Event or Problem Description
As reported, the patient had an initial left tka on (b)(6) 2020.The patient returned to the surgeon's office with complaints of pain, swelling, instability, and dissatisfaction with their tka.The patient has a recalled implant.Upon examination, the patient was scheduled for a revision tka possible poly swap vs.Full revision.The patient was revised on 16-oct-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.
Additional Manufacturer Narrative
The revision reported was likely the result of tibial insert prosthesis wear and instability.Possible causes for polyethylene wear include malalignment between the implants, inclusion of the polyethylene in the packaging recall, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.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.

• Brand Name: LOGIC TIB INSERT IMPL CRC, SZ 4, 15MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18089179
• Report Number: 1038671-2023-02713
• Device Sequence Number: 17628630
• Product Code: JWH
• UDI-Device Identifier: 10885862230515
• UDI-Public: 10885862230515
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• 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): 07/16/2025

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: 04/08/2021
• Device Catalogue Number: 02-012-51-4015
• 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: 10/17/2023
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2013
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 99 KG