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

Model Number	TRULIANT TIB IMP PS INSERT SZ 2.5 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Implant Pain (4561); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Additional information received from legal on 06-nov-2023: legal case ¿ usa.Patient id: (b)(6).Revision op report indications for procedure: patient had radiographic evidence of loosening.During surgery: the femur was noted to be quite loose and easily removed.Original description summary: additional information received from legal on 06-oct-2023: legal case ¿ usa.Patient id: (b)(6).Implant date: (b)(6)2021, dr.(b)(6).Explant date: (b)(6)2023, dr.(b)(6), op report attached.No device return anticipated due to this being a legal case.Ebi initial surgery attached.Original description summary: legal case: usa.Patient id: (b)(6).As reported via legal documentation, a patient had right knee replacement surgery on (b)(6) 2021.They underwent right knee revision surgery on (b)(6) 2023, approximately 2 years 2 months post primary procedure.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.Ebi not found.
Additional Manufacturer Narrative
The product associated with the reported event is within the scope of recall z-0023-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.D10 concomitants: (b)(6), 02-020-11-0325 - truliant ps cem fem ps cem right sz 2.5.(b)(6), 02-022-45-2525 - truliant tib fit tray cem sz 2.5f / 2.5t.(b)(6), 200-02-29 - three peg patella 29mm.(b)(6), a10012 - gps implant kit v2.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.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 26 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear and implant pain.Initial surgery and revision surgery operative notes were provided.Patient left the operating room in stable condition.No further issues or complications were reported.No additional information is available.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 2.5 9MM
• 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21218333
• Report Number: 1038671-2025-00366
• Device Sequence Number: 15613203
• 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: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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 Model Number: TRULIANT TIB IMP PS INSERT SZ 2.5 9MM
• Device Catalogue Number: 02-022-35-2509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/21/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2023
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2019
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male