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

Model Number	02-022-35-2509
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Joint Laxity (4526)
Date of Event	09/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 02-012-60-1425 - logic stem ext 14mm x 25mm 6381463, 02-020-11-0225 - truliant ps cem fem ps cem left sz 2.5 6451198, 02-022-45-2515 - truliant tib fit tray cem sz 2.5f / 1.5t 6271644, 200-02-35 - three peg patella 35mm 6376832, 204-70-00 - tibial stem ext.Screw 6305478, a10012 - gps implant kit v2 01026520097.Remedial action initiated: z-0023-2022.
Event or Problem Description
As reported, the patient had an initial left tka on (b)(6) 2020.The patient presented with discomfort, pain and instability issues.The patient was revised on (b)(6) 2020.The patient was last known to be in stable condition following the event.No other patient information/medical history provided.
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 subsequent revision and instability cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.The patient has multiple joint replacements, this suggests joint maladies.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d1, d4 (remove all-suspect product unknown), d8, h6 clinical code, device problem code, component code and investigation conclusion codes.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: TRULIANT KNEE COMPONENTS
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15624016
• Report Number: 1038671-2022-01312
• Device Sequence Number: 6183935
• Product Code: JWH
• UDI-Device Identifier: 10885862304162
• UDI-Public: 10885862304162
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2025

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: 02-022-35-2509
• Device Catalogue Number: 02-022-35-2509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/03/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2022
• Supplement Date Received by Manufacturer: 10/18/2022; 10/09/2025
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 11/03/2022; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2019
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female