MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 3.5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT TIB IMP PSC INSERT SZ 3.5, 9MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577); Crepitus (4893)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the legal brief, after a review of imaging, surgical intervention was recommended, and a right total knee replacement was scheduled and performed on (b)(6) 2019.Following extensive rehabilitation, patient experienced swelling and pain from the total knee replacement that continues to this day.Patient experiences a sensation that the right knee is unstable, drops, and detects a clicking sensation.On or around (b)(6) 2022, patient received a phone call from her surgeon who explained that both of her total knee replacements systems were recalled and informed her that both of her knees would need to be replaced again.Patient received a letter (b)(6) on (b)(6) 2022, which provided written notice that she received defective parts from an exactech knee replacement system and that the components were being recalled.Patient followed up with a visit to her surgeon and, upon surgeon¿s advice and recommendation, scheduled a corrective right total knee replacement surgery for (b)(6) 2023.
Additional Manufacturer Narrative
Concomitant products: logic stem ext 14mm x 25mm (cat# 02-012-60-1425 / serial# (b)(4)).Truliant ps cem fem ps cem right sz 3.5 (cat# 02-020-11-0335 / serial# (b)(4)).Truliant tib fit tray cem sz 3.5f / 2.5t (cat# 02-022-45-3525 / serial# (b)(4)).Advanced patella 32mm 3 peg implant (cat# 200-07-32 / serial# (b)(4)).Tibial stem ext.Screw (cat# 204-70-00 / serial# (b)(4)).As reported by the legal brief, after a review of imaging, surgical intervention was recommended, and a right total knee replacement was scheduled and performed on (b)(6) 2019.Following extensive rehabilitation, patient experienced swelling and pain from the total knee replacement that continues to this day.Patient experiences a sensation that the right knee is unstable, drops, and detects a clicking sensation.On or around (b)(6) 2022, patient received a phone call from her surgeon who explained that both of her total knee replacements systems were recalled and informed her that both of her knees would need to be replaced again.Patient received a letter (b)(6) on (b)(6) 2022, which provided written notice that she received defective parts from an exactech knee replacement system and that the components were being recalled.Patient followed up with a visit to her surgeon and, upon surgeon¿s advice and recommendation, scheduled a corrective right total knee replacement surgery for (b)(6) 2023.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent pain and upcoming revision cannot be conclusively determined; however it is most likely related to patient conditions as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.

• Brand Name: TRULIANT TIB IMP PSC INSERT SZ 3.5, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: julia goldberg ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15962020
• Report Number: 1038671-2022-01587
• Device Sequence Number: 20215339
• Product Code: JWH
• UDI-Device Identifier: 10885862305169
• UDI-Public: 10885862305169
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/19/2025
• Device Model Number: TRULIANT TIB IMP PSC INSERT SZ 3.5, 9MM
• Device Catalogue Number: 02-022-44-3509
• 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: 11/21/2022
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2017
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female