MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC TIBIAL FIT TRAY CEM SZ 3F / 3T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-45-3030
Medical Device Problem Codes	Unstable (1667); Migration (4003)
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
Event or Problem Description
Approximately 6 years and 28 days post-operatively of a right tka, it was reported via clinical study, that the 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 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.The case report form indicates this event is unlikely related to device and possibly related to procedure.
Additional Manufacturer Narrative
(d10) concomitants: serial#: (b)(6), category#: a10012 - gps implant kit v2, serial#: (b)(6), category#: 208-06-03 - cc distal fem augment sz 3, 10mm, serial#: (b)(6), category#: 02-012-50-3011 - logic fit/rbk augment 1/2 block sz 3, 5mm, serial#: (b)(6), category#: 02-012-50-3011 - logic fit/rbk augment 1/2 block sz 3, 5mm, serial#: (b)(6), category#: 208-06-03 - cc distal fem augment sz 3, 10mm, serial#: (b)(6), category#: 204-70-00 - tibial stem ext.Screw, serial#: (b)(6), category#: 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t, serial#: (b)(6), category#: 02-010-06-0330 - logic cc femoral size 3, right, serial#: (b)(6), category#: 02-012-60-1440 - logic stem ext 14mm x 40mm, serial#: (b)(6), category#: 02-012-60-1440 - logic stem ext 14mm x 40mm, serial#: (b)(6), category#: 02-012-61-2000 - logic offset stem ext coupler 2mm.
Additional Manufacturer Narrative
1038671-2023-00502, 1038671-2024-04176 this follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6 (type of investigation, investigation findings, investigation conclusions).The following sections were corrected: h6 (health effect - clinical 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 TIBIAL FIT TRAY CEM SZ 3F / 3T
• 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; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20567926
• Report Number: 1038671-2024-04178
• Device Sequence Number: 20680500
• Product Code: JWH
• UDI-Device Identifier: 10885862003966
• UDI-Public: 10885862003966
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K101981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: 07/26/2026
• Device Catalogue Number: 02-012-45-3030
• 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: 12/20/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2016
• 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 H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female