MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 4.5 11MM; SEE H10

Model Number	02-022-35-4511
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Arthralgia (2355); Joint Laxity (4526)
Date of Event	01/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.The truliant device with serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient's condition and revision surgery as related to the devices cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.
Event or Problem Description
It was reported via legal notification that a patient had an initial right knee arthroplasty on (b)(6) 2020 and then had a surgical revision on (b)(6) 2022.The revision surgery was approximately 2 years, after initial implant.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.
Event or Problem Description
Revision op report findings: all components were well fixed.The patella was left in place.There was a mild to moderate amount of normal-appearing joint fluid.There were no signed of infection.There was slight hyperextension along with subtle mid flexion instability.The patient was then taken to the recovery room in satisfactory condition there are no complications.There is no additional information available.
Additional Manufacturer Narrative
Additional manufacturer narrative- a2, a3, b5, h3.Updated investigation results-the cause of the patient¿s subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition of joint laxity as associated with the interaction between the implanted device and the patient that impacts the performance of the device.The patient was revised to a constrained device which will assist with joint laxity issues.These devices are used for treatment not diagnosis.There is no additional information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h3, h6, h11 the reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.A review of complaint history determined that no further action is required as no trends were identified.The reason for the reported revision in cannot be confirmed from the information provided but may be the result of prosthesis wear and instability or due to inclusion of the polyethylene in the packaging recall.However, the reported prosthesis wear and instability cannot be confirmed and potential contributions of user, or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images radiographs, or relevant clinical information were provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 4.5 11MM
• Common Device Name: SEE H10
• 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 ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 17007674
• Report Number: 1038671-2023-01146
• Device Sequence Number: 7150904
• Product Code: JWH
• UDI-Device Identifier: 10885862304544
• UDI-Public: 10885862304544
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 04/20/2026

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 Model Number: 02-022-35-4511
• Device Catalogue Number: 02-022-35-4511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 06/04/2024; 04/17/2026
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 06/04/2024; 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2019
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male