MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 2.5 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number	02-022-35-2509
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Synovitis (2094); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	08/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation, a patient had right knee replacement surgery on (b)(6) 2018.The patient claims they may need revision surgery, no scheduled surgery has been reported.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
Pending investigation.D10.Concomitants: 5482483 02-020-11-0325 - truliant ps cem fem ps cem right sz 2.5.5042353 02-022-45-2525 - truliant tib fit tray cem sz 2.5f / 2.5t.5611591 200-07-32 - advanced patella 32mm 3 peg implant.
Additional Manufacturer Narrative
1038671-2024-05018.1038671-2024-05017 this follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b3 d6b g4 h6 (health effect - clinical code, health effect - impact code, component code, type of investigation, investigation findings, investigation conclusions) the following sections were corrected: h6 (medical device problem code) the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and femoral loosening.The reported prosthesis wear and femoral loosening could not be confirmed.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.
Additional Manufacturer Narrative
Report number: 1038671-2024-05018, 1038671-2024-05017 this follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and femoral loosening.The reported prosthesis wear and femoral loosening could not be confirmed.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.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 2.5 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523782617
• MDR Report Key: 17393645
• Report Number: 1038671-2023-01767
• Device Sequence Number: 14086113
• Product Code: JWH
• UDI-Device Identifier: 10885862304162
• UDI-Public: 10885862304162
• 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: 2018
• 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): 01/08/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/03/2026
• Device Catalogue Number: 02-022-35-2509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2023
• Supplement Date Received by Manufacturer: 12/20/2024; Not provided
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 12/27/2024; 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2018
• 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 H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female