MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 2.5 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-2510
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6) 02-022-45-2515 - truliant tib fit tray cem sz 2.5f / 1.5t.(b)(6) 02-022-45-2525 - truliant tib fit tray cem sz 2.5f / 2.5t.(b)(6) 02-012-60-1425 - tru stem ext 14mm x 25mm.(b)(6) 200-02-32 - three peg patella 32mm.(b)(6) 204-70-00 - tibial stem ext.Screw.
Additional Manufacturer Narrative
H10: pending investigation.There is no other information provided.
Event or Problem Description
It was reported via legal documentation that a patient had a right knee arthroplasty on (b)(6) 2020, and then experienced a revision surgical procedure on (b)(6) 2023, approximately 3 years, 5 months after initial implant.There was no other patient/medical information provided.No x-rays or images were provided.The device will not be returned.There is no other information available.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, tibial loosening, and femoral loosening 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.H6: corrected health effect, medical device and investigation clinical codes.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 2.5 10MM
• 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 INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; gainesville 32653
• MDR Report Key: 19382169
• Report Number: 1038671-2024-01431
• Device Sequence Number: 20457982
• Product Code: JWH
• UDI-Device Identifier: 10885862304179
• UDI-Public: 10885862304179
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2025

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 Catalogue Number: 02-022-35-2510
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 08/08/2024; 03/31/2025
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 08/14/2024; 03/31/2025
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown