MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 2 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number	02-012-35-2013
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Implant Pain (4561); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation, a patient had left knee replacement surgery on(b)(6) 2019.They have not yet undergone revision surgery but have consulted with a surgeon for reasons not reported.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Pending investigation.D10.Concomitants: 02-012-42-2008 - logic pts, size 2, 8mm 4523723.204-34-04 - fluted stem extension 40l x 14 mm 5367857.208-04-23 - trap tray, offset alpha cem, sz 1f/2t & 4405840.
Additional Manufacturer Narrative
These devices are used for treatment not diagnosis.Pending investigation.There is no other information available.
Event or Problem Description
Additional information was reported that a patient had a revision surgery of the left total knee on (b)(6) 2023, approximately 4 years, 5 months after implant.The patient presented to the doctor's office with complaints of their bilateral total knee replacements.Upon examination, poly wear and osteolysis was "evident".The patient underwent a poly insert swap to a psc poly.Photos and x-rays were obtained.The devices will not be returned.The patient was last known to be in stable condition following the event.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 corrected: h6.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear or due to inclusion of the polyethylene in the packaging recall.Additionally, contributing factors to the reported wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years and/or implantation of incompatible tibial and femoral components.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear or due to inclusion of the polyethylene in the packaging recall.Additionally, contributing factors to the reported wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years and/or implantation of incompatible tibial and femoral components.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation.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 2 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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 court; gainesville 32653 ; 3523782617
• MDR Report Key: 17607649
• Report Number: 1038671-2023-02032
• Device Sequence Number: 20364812
• Product Code: JWH
• UDI-Device Identifier: 10885862001740
• UDI-Public: 10885862001740
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/17/2025

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: 03/24/2020
• Device Catalogue Number: 02-012-35-2013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 08/25/2023; Not provided; 01/16/2025
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 09/28/2023; 01/17/2025; 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2012
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female