MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 5 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC TIBIA PS MOD INSRT SZ 5 13MM
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Joint effusion (4849)
Date of Event	06/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately seven years post left revision tka, the 72 y/o male patient begin to experience spill and pain.Then, three months later lysis on femoral and tibial was observed.The patient was revised to competitor's device on (b)(6) 2023.No additional information available.
Additional Manufacturer Narrative
(h3) the revision reported was likely the result of osteolysis.Additionally, a contributing factor to the osteolysis may have been the result of the tibial insert being packaged in a non-conforming vacuum bag for more than five years, which increases the risk of polyethylene wear due to premature oxidation.The extent and root cause of the osteolysis could not be determined as the devices were not returned for evaluation, and images and radiographs were not provided.The most probable root cause associated with the event of ¿osteolysis¿ is associated with destruction or disappearance of bone tissue likely related to weakened integration of an implant at the bone-implant interface.
Additional Manufacturer Narrative
*the following sections have corrected information: (h3) the revision reported was likely the result of osteolysis.Additionally, a contributing factor to the osteolysis may have been the result of the tibial insert being packaged in a non-conforming vacuum bag for more than five years, which increases the risk of polyethylene wear due to premature oxidation.The extent and root cause of the osteolysis could not be determined as the devices were not returned for evaluation, and images and radiographs were not provided.(h6) health effect - clinical code, medical device problem code, type of investigation, investigation findings, investigation conclusion.
Additional Manufacturer Narrative
After additional review of information and an update to the investigation, the following sections g1, g3, g6, h1, h2, and h6 have been updated accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: e.The revision reported was likely the result of prosthesis wear and osteolysis.A contributing factor to the prosthesis wear may have been the result of the tibial insert being packaged in a non-conforming vacuum bag for more than five years.The reported osteolysis could not be confirmed as radiographs were not provided; however, prosthesis wear could be confirmed.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 5 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: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18040187
• Report Number: 1038671-2023-02643
• Device Sequence Number: 15308461
• Product Code: JWH
• UDI-Device Identifier: 10885862001948
• UDI-Public: 10885862001948
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/19/2025

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: 11/08/2018
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 5 13MM
• Device Catalogue Number: 02-012-35-5013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2023
• Supplement Date Received by Manufacturer: 11/06/2023; 08/07/2024; 11/01/2024; 12/11/2025
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 12/06/2023; 09/04/2024; 11/14/2024; 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2010
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 90 KG