MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 1 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC TIBIA PS MOD INSRT SZ 1 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.D10: concomitants: 4045435 02-010-01-0210 - femur ps cem.Nº1 izq.4021134 02-012-45-1010 - bandeja tibial logic fit 1f/1t.4282456 204-34-04 - vastago ext.14x40mm.4232175 204-70-00 - tornillo fijacion vástago a tibia.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
Ubarmin #31 during the week of april 17-25, representatives of exactech, inc.And exactech spain conducted an in person site visit with (b)(6) hospital.As a result of that site visit and at exactech's request, the hospital provided a retrospective excel listing of revision related to polyethylene wear that have been performed since 2010.These cases have not previously been reported to exactech as complaints.On 28-nov-2023 updates to the excel listing were provided.This patient (b)(6) was implanted with a 02-012-35-1009 logic tibia ps mod insrt sz 1 9mm, serial number (b)(6) on (b)(6) 2016.The insert was manufactured on 3/24/2015 and was packaged in a vacuum bag with no evoh.The insert was manufactured on 3/24/2015 and was 1.02 years shelf age at the time of implant.Pending revision for wear of the polyethylene.No additional details are available at this time.
Additional Manufacturer Narrative
H3: the prosthesis wear reported may have been due to third body wear, patient-related conditions, instability, and/or malalignment between the femoral and tibial components.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.However, this cannot be confirmed as the device was not available for evaluation, and images and radiographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The prosthesis wear reported may have been due to third body wear, patient-related conditions, instability, and/or malalignment between the femoral and tibial components.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.However, this cannot be confirmed as the device was not available for evaluation, and images and radiographs 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 PS MOD INSRT SZ 1 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 66 court; gainseville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18352559
• Report Number: 1038671-2023-03019
• Device Sequence Number: 8406746
• Product Code: JWH
• UDI-Device Identifier: 10885862001689
• UDI-Public: 10885862001689
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/23/2023
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 1 9MM
• Device Catalogue Number: 02-012-35-1009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 03/27/2024; 05/15/2025
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 04/01/2024; 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown