MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Catalog Number	02-012-35-3015
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	01/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants medical products: serial #: (b)(4), category #: a10012 - gps implant kit v2.Serial #: (b)(4), category #: 208-06-03 - cc distal fem augment sz 3, 10mm.Serial #: (b)(4), category #: 02-012-50-3011 - logic fit/rbk augment 1/2 block sz 3, 5mm.Serial #: (b)(4), category #: 02-012-50-3011 - logic fit/rbk augment 1/2 block sz 3, 5mm.Serial #: (b)(4), category #: 208-06-03 - cc distal fem augment sz 3, 10mm.Serial #: (b)(4), category #: 204-70-00 - tibial stem ext.Screw.Serial #: (b)(4), category #: 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t.Serial #: (b)(4), category #: 02-010-06-0330 - logic cc femoral size 3, right.Serial #: (b)(4), category #: 02-012-60-1440 - logic stem ext 14mm x 40mm.Serial #: (b)(4), category #: 02-012-60-1440 - logic stem ext 14mm x 40mm.Serial #: (b)(4), category #: 02-012-61-2000 - logic offset stem ext coupler 2mm.
Event or Problem Description
It was reported via clinical study, that the 56 yo female patient experienced prepatellar bursitis of the right knee causing pain, swelling, and locking in right knee joint.Small joint effusion and prepatellar subcutaneous edema was noted on the mri.The date of adverse event onset is (b)(6) 2022.The treatment recommended was exploration of knee joint with revision of tibial insert and rebalancing of knee joint.The patient¿s outcome was last known as continuing.
Event or Problem Description
It was reported via clinical study, that the 56 yo female patient experienced prepatellar bursitis of the right knee causing pain, swelling, and locking in right knee joint.Small joint effusion and prepatellar subcutaneous edema was noted on the mri.The date of adverse event onset is 09-13-2022.The treatment recommended was exploration of knee joint with revision of tibial insert and rebalancing of knee joint.The patient¿s outcome has been updated to resolved by revision surgery on (b)(6) 2023.The case report form indicates this event is definitely related to device and possibly related to procedure.This event report was received through clinical data collection activities and no device return is anticipated.
Additional Manufacturer Narrative
1038671-2024-04176, 1038671-2024-04178 this follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b3, h6 (type of investigation, investigation findings, investigation conclusions).The following sections were corrected: h6 (health effect - clinical code, health effect - impact code, medical device problem code, component code).The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, tibial subsidence, instability and/or due to inclusion of the polyethylene in the packaging recall.Additionally, a contributing factor to the reported wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.Prior patient related conditions also may have contributed to the reported events.Potential contributions of user related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information 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: OPTETRAK LOGIC
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: geoff gannon ; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16606869
• Report Number: 1038671-2023-00502
• Device Sequence Number: 4738581
• Product Code: JWH
• UDI-Device Identifier: 10885862001832
• UDI-Public: 10885862001832
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/26/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/15/2019
• Device Catalogue Number: 02-012-35-3015
• 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: 02/27/2023
• Supplement Date Received by Manufacturer: 02/27/2023; 12/20/2024
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 04/08/2024; 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2011
• 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: Required Intervention; Other
• Patient Age: 56 YR
• Patient Sex: Female