MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT; SEE H10

Catalog Number	02-022-44-4013
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Pain (1994); Implant Pain (4561); Joint effusion (4849)
Date of Event	07/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Procode: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomitant medical products: (b)(4) 02-010-01-0240 - logic femoral ps cem left sz 4; (b)(4) 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t; (b)(4) 200-02-38 - three peg patella 38mm; (b)(4) 204-34-02 - fluted stem extension 25l x 14 mm; (b)(4) 204-70-00 - tibial stem ext.Screw.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported via a legal notification, that patient underwent a left knee revision surgery on (b)(6) 2021 and was implanted with another recalled exactech optetrak device.On (b)(6) 2021 plaintiff underwent another revision surgery, approximately 1 month post revision procedure, and was again implanted with an exactech optetrak device.No device return anticipated due to this being a legal case.No further information.
Additional Manufacturer Narrative
Additional information: d1, d4 all, d10, g 4 510k, h4, h7 & h9.D10.Concomitants: 6673570; 02-010-06-0240 - logic cc femoral size 4, left.6018494; 02-010-06-0541 - logic post.Aug.Block size 4, 5mm.6765266; 02-012-61-4000 - logic offset stem ext coupler 4mm.5132191; 02-012-64-1612 - tru fluted stm ext 16mm x120mm blast.6693763; 208-05-04 - cc distal fem augment sz 4, 5mm.
Additional Manufacturer Narrative
Additional information: b5, b7 h6, investigation findings.H6.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause pain and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.
Event or Problem Description
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
H6: health effect - clinical code, medical device problem code, component code, type of investigation.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2025-02234.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and infection and instability or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were 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.
Event or Problem Description
It was reported that approximately 67 months after a left total knee replacement procedure, underwent a revision procedure.Approximately 1 month post revision procedure, and the patient underwent a second revision procedure to address pain, recurrent effusions, and an infection.Pre-surgery, the patient's knee was aspirated.His cell count was found to be 38,500 and he was growing staphylococcus lugdunensis.Revision operative notes were provided.The surgeon performed irrigation and debridement and polyethylene exchange.The patient tolerated the procedure well, there were no complications, and he was transferred to the pacu in stable condition.No additional information is available.

• Brand Name: TRULIANT TIB IMP PSC INSERT
• 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: kate jacobson ; 3523771140
• MDR Report Key: 16432517
• Report Number: 1038671-2023-00213
• Device Sequence Number: 2621923
• Product Code: JWH
• UDI-Device Identifier: 10885862305305
• UDI-Public: 10885862305305
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 06/04/2025

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: 09/14/2025
• Device Catalogue Number: 02-022-44-4013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2023
• Supplement Date Received by Manufacturer: 04/11/2023; 04/13/2023; 06/04/2025
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 04/11/2023; 04/13/2023; 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2017
• 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-0023-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.; SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male