MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-022-44-4009
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 02-020-11-0240 - truliant ps cem fem ps cem left sz 4; 02-022-45-4030 - truliant tib fit tray cem sz 4f / 3t; 200-07-35 - advanced patella 35mm 3 peg implant.
Event or Problem Description
As reported by the exactech truliant knee clinical study, approximately 1.5 years post op the initial tka, this 63 y/o male patient was revised due pain in left knee.Patient ran his knee into a door frame.He is now having pain.Femoral patella, tibial insert, tibial tray were revised.The case report form indicates this event is definitely not related to devices or procedure.This event report was received through clinical data collection activities.
Additional Manufacturer Narrative
Section h10: (h3) upon review of all available information, there is no evidence to suggest that a design or manufacturing issue caused or contributed to this event.The reported revision was likely the result of pain following the post traumatic event of the patient running his knee into a door frame.Section h11: the following sections have corrected information: (b5) describe event or problem: as reported by the exactech truliant knee clinical study, approximately 1.5 years post op the initial left total knee arthroplasty (tka) for osteoarthritis, this 63 y/o male at 180 lbs.Was revised due pain in his left knee.Femoral patella, tibial insert, and tibial tray were revised on (b)(6) 2021.The patient ran his knee into a door frame in (b)(6) 2021 (¿he is now having pain.¿).The patient had a knee aspiration on (b)(6) 2021.The case report form indicates this event is definitely not related to devices or procedure.The patient has a comorbidity of hypertension.There is no other reported information.
Event or Problem Description
As reported by the exactech truliant knee clinical study, approximately 1.5 years post op the initial left total knee arthroplasty (tka) for osteoarthritis, this 63 y/o male at 180 lbs.Was revised due pain in his left knee.Femoral patella, tibial insert, and tibial tray were revised on (b)(6) 2021.The patient ran his knee into a door frame in (b)(6) 2021 (¿he is now having pain.¿).The patient had a knee aspiration on (b)(6) 2021.The case report form indicates this event is definitely not related to devices or procedure.The patient has a comorbidity of hypertension.There is no other reported information.

• Brand Name: TRULIANT TIB IMP PSC INSERT SZ 4, 9MM
• 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: 14935940
• Report Number: 1038671-2022-00756
• Device Sequence Number: 5631636
• Product Code: JWH
• UDI-Device Identifier: 10885862305268
• UDI-Public: 10885862305268
• 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: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2022

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: 02-022-44-4009
• Device Catalogue Number: 02-022-44-4009
• 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: 06/15/2022
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 82 KG