MAUDE Adverse Event Report: EXACTECH, INC. LOGIC; SEE H10

Model Number	LOGIC TIBIA PS MOD INSRT SZ 3 13MM
Medical Device Problem Codes	Mechanical Problem (1384); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	08/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer concomitants: 02-010-01-0230 - logic femoral ps cem left sz 3 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t 200-02-38 - three peg patella 38mm femoral stem additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported via exactech knee replacement study, that a 66 yo male patient, who had an initial left knee implanted on (b)(6) 2016, due to osteoarthritis, was revised on (b)(6) 2023, approximately 7 years 1 month post the initial procedure.The patient had reduction in bending the left knee with noticeable effusion within the joint.Date of onset, (b)(6) 2022.Polyethylene wear without evidence of osteolysis was indicated, and an arthroscopic wash out was performed on (b)(6) 2022.On (b)(6) 2023, a left tkr was performed, and the poly was exchanged.The case report form indicates this event is possibly related to devices and to procedure.The outcome indicates the event was resolved on the revision date.No device returns anticipated due to the clinical study guidelines.No further information.
Additional Manufacturer Narrative
H3: the revision reported may have been the result of malalignment between the femoral and tibial components, third body wear, patient-related conditions, instability, or any combination of these possibilities, which led to wear of the polyethylene insert and patella component.However, this cannot be confirmed as the devices were not returned for evaluation and images of the explanted devices and pre-revision radiographs were not provided.The most probable root cause for the reported event of "prosthesis wear" is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.
Event or Problem Description
Approximately 5 year(s), 5 month(s) and 17 day(s) post-operative of a left tka, it was reported via clinical study that the patient experienced polyethylene wear without evidence of osteolysis.Approximately 11 months prior, the patient underwent an arthroscopic washout procedure reported on 1038671-2024-04721 and 1038671-2024-04722 with the outcome as continuing.The patient underwent a revision for poly exchange with the reported revision of the patella, and poly components.The outcome of this event is considered resolved and the case report form indicates that this event is possibly related to the device and/or to the procedure.This was reported through clinical trial study data collection activities and no other information is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: a2, h6 - clinical & impact codes, medical device problem code, investigation findings and conclusion.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.A review of complaint history determined that no further action is required as no trends were identified.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-04726.A definitive root cause was unable to be determined; however, may have resulted from malalignment between the femoral and tibial components, third body wear, patient-related conditions, instability, or any combination of these possibilities, which led to wear of the polyethylene insert and patella component.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC
• Common Device Name: SEE H10
• 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 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18478412
• Report Number: 1038671-2024-00054
• Device Sequence Number: 6408107
• Product Code: JWH
• UDI-Device Identifier: 10885862001825
• UDI-Public: 10885862001825
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K033883
• 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: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/09/2024

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 Model Number: LOGIC TIBIA PS MOD INSRT SZ 3 13MM
• Device Catalogue Number: 02-012-35-3013
• 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: 12/11/2023
• Supplement Date Received by Manufacturer: 05/15/2024; 12/03/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 05/30/2024; 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 72 KG