MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS POR FEM PS POR LEFT SZ 3; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS

Model Number	02-020-12-0230
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Joint effusion (4849); Aseptic loosening (4883)
Date of Event	01/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: serial #: (b)(4), category #: 02-029-99-1001 - fluted headless pin 3.0" square head, pk2, serial #: (b)(4), category #: 02-029-99-1002 - threaded head pin 2.3" square head, pk2, serial #: (b)(4), category #: 02-022-55-3020 - truliant por tib tray size 3f/2t, serial #: (b)(4), category #: 200-07-35 - advanced patella 35mm 3 peg implant, serial #: (b)(4), category #: 02-022-35-3009 - truliant tib imp ps insert sz 3 9mm.Recall number: z-0023-2022.
Event or Problem Description
As reported, the patient had an initial left tka on (b)(6) 2021.The patient complained of pain and was revised on (b)(6) 2023 due to a recalled poly.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.
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 cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
H3: investigation results - the revision reported was likely the result of an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening.The extent and root cause of the femoral loosening could not be determined as the devices were not returned for evaluation.Initial submission: all fields in section f should be blank, this is a manufacturer's report.
Event or Problem Description
Revision was approximately 1 year, 7 months post implant.Revision operative report of (b)(6) 2023-revised to competitor devices- femur, tibial baseplate, insert.Postoperative diagnoses: failed left total knee arthroplasty secondary to a recalled polyethylene insert and aseptic loosening of the femoral component.Procedure: there was significant synovitis with thickening of the synovial tissue.Cleared out the scar tissue from around the patellar button, this was in good condition and well fixed.Removed the previous tibial insert, on gross inspection, there was no evidence of wear.The femoral component was grossly loose from the femur, disimpacted with no bone loss.Tibial component disimpacted from the proximal tibia with minimal bone loss.Devices were trialed and then implanted.Sterile dressings applied, the patient was awoken from anesthesia and transferred to the recovery room in stable condition.Once she is medically stable, to be discharged home with outpatient physical therapy.

• Brand Name: TRULIANT PS POR FEM PS POR LEFT SZ 3
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS
• 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: miguel sosa ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16315829
• Report Number: 1038671-2023-00119
• Device Sequence Number: 15411057
• Product Code: MBH
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K181794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 06/15/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02-020-12-0230
• Device Catalogue Number: 02-020-12-0230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2023
• Supplement Date Received by Manufacturer: 06/12/2023; 01/16/2024; 06/15/2026
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 06/26/2023; 01/30/2024; 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2019
• 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: Required Intervention; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Female