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

Model Number	02-022-47-3509
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Unspecified Musculoskeletal problem (4535)
Date of Event	09/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the exactech knee replacement study, approximately 3 months post op the initial tka, this 53 y/o female patient was experiencing increased pain and stiffness.The case report form indicates this event is possibly related to devices and unlikely related procedure.This event report was received through clinical data collection activities.Action taken: medication.X-rays.Follow up in four months per doctor's instructions.
Additional Manufacturer Narrative
Concomitant medical products: 02-020-14-0235 - truliant cr por fem cr por left sz 3.5 sn: (b)(4), 02-022-55-3525 - truliant por tib tray size 3.5f/2.5t sn: (b)(4), 200-07-32 - advanced patella 32mm 3 peg implant sn: (b)(4),.
Event or Problem Description
As reported by the exactech knee replacement study, approximately 3 months post op the initial left tka for primary osteoarthritis, this 53 y/o obese female patient was experiencing increased pain and stiffness.The case report form indicates this event is possibly related to devices and unlikely related procedure.Action taken: medication.X-rays.Follow up in four months per doctor's instructions.Follow up was on (b)(6) 2022; action taken: none; outcome: resolved.This event report was received through clinical data collection activities.No additional information was provided.
Additional Manufacturer Narrative
Section h10: (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 pain cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.Section h11: *the following sections have corrected information: (b5) describe event or problem: as reported by the exactech knee replacement study, approximately 3 months post op the initial left tka for primary osteoarthritis, this 53 y/o obese female patient was experiencing increased pain and stiffness.The case report form indicates this event is possibly related to devices and unlikely related procedure.Action taken: medication.X-rays.Follow up in four months per doctor's instructions.Follow up was on (b)(6) 2022; action taken: none; outcome: resolved.This event report was received through clinical data collection activities.No additional information was provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d1, d4 (remove all from initial report-suspect device unknown), d8, g4 (remove 501k from initial report-unknown), h2, h3, h4 (remove manufacture date from initial report-unknown), h6 clinical code, health impact code, type of investigation, investigation findings, 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, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15391196
• Report Number: 1038671-2022-01075
• Device Sequence Number: 6198541
• Product Code: JWH
• UDI-Device Identifier: 10885862306425
• UDI-Public: 10885862306425
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/21/2026

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: 01/17/2026
• Device Model Number: 02-022-47-3509
• Device Catalogue Number: 02-022-47-3509
• 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: 08/23/2022
• Supplement Date Received by Manufacturer: 10/10/2022; 01/15/2026
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 10/27/2022; 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2018
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White