MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 11MM; SEE H10

Model Number	02-012-44-2011
Medical Device Problem Codes	Crack (1135); Unstable (1667); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	02/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer these devices are used for treatment not diagnosis.Pending investigation.There is no other information available.
Event or Problem Description
It was reported via legal documentation that this patient had an initial left total knee arthroplasty on (b)(6) 2014 and then approximately 8 years, 5 months later experienced a surgical revision on (b)(6) 2023.Patient revised to competitor¿s devices.Revision operative report of (b)(6) 2023.Post operative diagnosis: poly wear, instability, aseptic loosening of femoral component.Clinical history-patient presents with painful tka and recalled parts.The patient is found to have progressive polyethylene wear as well as instability of the total knee.Procedure: the patellar button was found to be intact with some surface wear.The polyethylene was noted to be grossly damaged with cracks throughout.The femoral component was completely debonded from its cement mantle.When femoral component was removed aori type iia bone loss was found, worse on the lateral compared to medial side, and osteolysis affecting both posterior condyles.Tibial component was removed with minimal bone loss.Bone loss of the tibial metaphysis warranted the use of a cone.The patellar component was removed.Components were trialed and then the devices were implanted.Dressings were applied, the patient was transferred to the recovery room in stable condition.To be discharged home when all pt goals are met, and patient is comfortable.Hospital care: admitted (b)(6) 2023/ discharged 12 feb 2023.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: a, b, c, d, e, g.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, cracking and failure of the cement used to secure the femoral component to the femoral bone, which led to loosening at the cement-implant interface, or due to inclusion of the polyethylene in the packaging recall.Potential contributions of manufacturing, user, and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and product information were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 11MM
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 17267733
• Report Number: 1038671-2023-01566
• Device Sequence Number: 5911522
• Product Code: JWH
• UDI-Device Identifier: 10885862173485
• UDI-Public: 10885862173485
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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
• Report Date (Section B): 08/06/2025

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: 10/29/2020
• Device Model Number: 02-012-44-2011
• Device Catalogue Number: 02-012-44-2011
• 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: 05/05/2023
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2012
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female