MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	UNKNOWN TRULIANT COMPONENT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	12/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the legal brief, on (b)(6) 2017, patient was implanted with the device which failed prematurely, causing pain and difficulty walking, among other injuries and ailments.Recently, patient began experiencing pain, instability, swelling, and difficulty walking, among other injuries and ailments.After (b)(6) 2022, patient received a recall letter regarding his exactech device, and his physician confirmed that he was implanted with a now-recalled device.Patient¿s physician discussed with patient his concerns regarding his recalled exactech polyethylene insert as well as the pain and discomfort patent was recently experiencing.On or about (b)(6) 2022, patient visited hospital at which time he had fluid drawn from his painfully swollen left knee, received a cortisol shot, and was informed that he would need to undergo a revision surgery.Patient is currently waiting to be scheduled for revision surgery which is likely to occur in the coming months.
Additional Manufacturer Narrative
Concomitant products: truliant ps cem fem ps cem left sz 4.5 (cat# 02-020-11-0245 / serial# (b)(4).Truliant tib fit tray cem sz 4.5f/3.5t (cat# 02-022-45-4535 / serial# (b)(4).Advanced patella 35mm 3 peg implant (cat# 200-07-35 / serial# (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H3: 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 patient¿s pain cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition 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.These devices are used for treatment not diagnosis.

• Brand Name: TRULIANT
• 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16440774
• Report Number: 1038671-2023-00229
• Device Sequence Number: 15315338
• Product Code: JWH
• UDI-Device Identifier: 10885862304582
• UDI-Public: 10885862304582
• 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: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/24/2025
• Device Model Number: UNKNOWN TRULIANT COMPONENT
• Device Catalogue Number: 02-022-35-4515
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 05/08/2023; Not provided
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 05/16/2023; 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2017
• 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: Required Intervention
• Patient Sex: Male