MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Osteolysis (2377); Ambulation or Postural Difficulties (2544); Implant Pain (4561)
Date of Event	10/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Legal case - usa related to: case (b)(4).Additional information received from legal on 24-oct-2023/ reviewed by sc on 11-mar-2024 - it was reported via legal documentation that a patient had a left total knee arthroplasty on (b)(6) 2018 and then experienced a revision surgical procedure on (b)(6) 2023 approximately 5 years and 5 months after initial implant.There is no device information provided.No images of the devices are provided.The device will not be returned.There is no other information available.This patient is verified bilateral knee arthroplasty.The patient had left knee revision on (b)(6) 2023 (op report attached).On (b)(6) 2024, sc - revision operative report of (b)(6) 2023: patient was revised to competitor's devices/ postoperative diagnosis:1.Femoral component was found to be significantly loose.2.Tibial component was found to be well fixed.3.There was some burnishing in the polyethylene insert but no significant gross wear.There were no intraoperative complications, the patient was taken to recovery room in stable condition.As directed by qa management: this legal complaint case is from the united states.The event did not occur in, nor is it reportable for brazil, canada, eea/eu, japan, taiwan, or great britain, excluding northern ireland.Therefore, only the us reportability determination will be assessed.Original description summary: patient is verified bilateral knees with dr (b)(6).He is scheduled left knee revision on (b)(6) 2023.Dr (b)(6) prescribed this for strengthening ahead of revision; define fitness personal trainer (b)(6) 10 sessions at (b)(6) each total (b)(6).See attached letter of medical necessity for pt w/ trainer from dr.(b)(6).(b)(6) is patient currently under my care.He has chronic, persistent pain in the total knee replacement.As part of his treatment plan, i advised the patient to undergo a goal-directed medically supervised physical therapy program with a trainer.According to advanced imaging there is a large area of osteolysis involving the medial plateau with areas of destruction of the medial cortex.With these results, it is likely the patient's rehabilitation may be delayed given the patient's age and mobility issues.Mr.(b)(6) is scheduled for revision knee replacement on (b)(6) 2023.It is advisable for the patient to strengthen the leg to help towards a speedy recovery.No device return anticipated due to this being a legal case.No ebi initial surgery results found.Qad serial trace attached.Historical records & smartsolve searched for sn/patient name with no results.No further information.
Additional Manufacturer Narrative
The product associated with the reported event is within the scope of recall z-0021-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported via legal documentation that a patient had a left total knee arthroplasty on (b)(6) 2018 and then experienced a revision surgical procedure on (b)(6) 2023 approximately 5 years and 5 months after initial implant.There is no device information provided.No images of the devices are provided.The device will not be returned.There is no other information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.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 4, 9MM
• 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: 20879354
• Report Number: 1038671-2024-04699
• Device Sequence Number: 12683490
• Product Code: JWH
• UDI-Device Identifier: 10885862173638
• UDI-Public: 10885862173638
• 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: 2018
• 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): 03/26/2025

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: 09/25/2021
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM
• Device Catalogue Number: 02-012-44-4009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/24/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2023
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 03/26/2025
• Date Device Manufactured: 10/01/2013
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male