MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 13MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
Legal case ¿ (b)(6) rev.As reported via legal documentation the patient had a right knee replacement on (b)(6)2016.Approximately 6 years and 4 years after the initial procedure the patient had a right knee revision on (b)(6)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.Revision op report on (b)(6)2023 diagnosis: loosening of prosthesis of total right knee replacement the patellar button was found to be intact but with some surface wear.The femur - could easily tamp off the femoral component which was noted to have completely debonded from its cement mantle.There was noted to be aori type i bone loss, mild osteolysis affecting both medial and lateral condyles.The tibia - tibial component was found to be loose.Bony inventory after removal cement of the tibia revealed type i bone loss.The patient was transferred to the recovery room in stable condition.Unable to locate surgeon/patient/serial number in ebi.No serial numbers available.Historical record and smartsolve searched for sn/patient name with no results.
Event or Problem Description
As reported via legal documentation the patient had a right knee replacement.Approximately 6 years and 4 years after the initial procedure the patient had a right knee revision.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 corrected information.The following sections were corrected: b5.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, 13MM
• 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
• MDR Report Key: 21118681
• Report Number: 1038671-2025-00181
• Device Sequence Number: 18027168
• Product Code: JWH
• UDI-Device Identifier: 10885862173492
• UDI-Public: 10885862173492
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

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: 07/18/2024
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 13MM
• Device Catalogue Number: 02-012-44-2013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/06/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 03/14/2025
• Date Device Manufactured: 07/19/2016
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Unknown