MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 4.5 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	TRULIANT TIB IMP PS INSERT SZ 4.5 9MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932); Pain (1994); Scar Tissue (2060); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Fibrosis (3167); Joint Laxity (4526); Swelling/ Edema (4577); Joint effusion (4849); Arthrofibrosis (4885)
Date of Event	02/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation the 59 y/o male patient had a right knee replacement on (b)(6) 2020.Approximately 2 years and 5 months after the initial procedure the patient had a right knee revision on (b)(6) 2023.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report on (b)(6) 2023: postoperative diagnosis: prosthetic wear and arthrofibrosis of right total knee arthroplasty.There was wear on the polyethylene component and on the tibial insert component of the right total knee arthroplasty.There was arthrofibrosis present within the joint.Findings: the patient was noted to have a right total knee arthroplasty.There was wear on the polyethylene component and on the tibial insert component of the right knee.There was arthrofibrosis present within the joint.The patient was taken from the operating room to the recovery room in stable condition.No complications were encountered.
Additional Manufacturer Narrative
D10: concomitants: 5968758, 02-022-45-4535 - truliant tib fit tray cem sz 4.5f/3.5t.6359450, 201-78-15 - holding pin mini sharp point 4 pk.6490460, 02-020-11-0345 - truliant ps cem fem ps cem right sz 4.5.6516714, 200-02-35 - three peg patella 35mm.Ab6165, 1200-i - cemex isoplastic 40g.S040802, 521-78-31 - threaded pin size 2.6 collarless 2pk.S048608, 521-78-31 - threaded pin size 2.6 collarless 2pk.S064281, 521-78-23 - threaded pin size 2.3 collared 2pk.S089723, 521-78-31 - threaded pin size 2.6 collarless 2pk.Pending investigation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3/g4, h6.The following sections were corrected: h6.Mdr section codes updated/corrected: e.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
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 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.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 4.5 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• 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: kate jacobson ; 3523771140
• MDR Report Key: 17083301
• Report Number: 1038671-2023-01279
• Device Sequence Number: 20419489
• Product Code: JWH
• UDI-Device Identifier: 10885862304520
• UDI-Public: 10885862304520
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2025

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 Model Number: TRULIANT TIB IMP PS INSERT SZ 4.5 9MM
• Device Catalogue Number: 02-022-35-4509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2023
• Supplement Date Received by Manufacturer: 01/15/2025; 05/22/2025
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 01/24/2025; 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2018
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male