MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM RIGHT SZ 1.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	02-020-11-0315
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Periprosthetic fracture (4902)
Date of Event	11/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.02-022-44-1509 truliant tib imp psc insert sz 1.5, 9mm; 02-022-45-1525 truliant tib fit tray cem sz 1.5f / 2.5t; 200-07-29 advanced patella 29m 3 peg implant; 02-029-99-1002 threaded head pin 2.3" square head, pk2.
Event or Problem Description
As reported, this 79 year old, female patient had an initial right side tka on (b)(6) 2019.The patient presented with a l distal femur fx on (b)(6) 2019 and was revised on (b)(6) 2019.Outcome: resolved.
Additional Manufacturer Narrative
Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the surgical event cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b3, d8, g1, h6 clinical code, health impact code, device problem code, component code, investigation findings, investigation conclusion codes.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the surgical event cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: TRULIANT PS CEM FEM PS CEM RIGHT SZ 1.5
• 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: ashley harris ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15173682
• Report Number: 1038671-2022-00884
• Device Sequence Number: 12030305
• Product Code: JWH
• UDI-Device Identifier: 10885862314512
• UDI-Public: 10885862314512
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2026

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 Model Number: 02-020-11-0315
• Device Catalogue Number: 02-020-11-0315
• 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: 07/19/2022
• Supplement Date Received by Manufacturer: 08/15/2022; 03/23/2026
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 09/02/2022; 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 74 KG