MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM LEFT SZ 3; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	02-020-11-0230
Medical Device Problem Codes	Mechanical Problem (1384); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932); Pain (1994); Scar Tissue (2060); Synovitis (2094); Osteolysis (2377); Joint effusion (4849)
Date of Event	03/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the female patient had an initial bilateral tka on (b)(6) 2019.The patient complained of pain and her left knee was revised on (b)(6) 2023 due to loose femur and recalled poly.This event is not related to the breakage of a device and there is no reported 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
Pending investigation.Concomitant medical products: 5065061, 02-022-35-3010truliant tib imp ps insert sz 3 10mm.5887641, 02-022-45-3020 - truliant tib fit tray cem sz 3f / 2t.5634563, 200-07-32 - advanced patella 32mm 3 peg implant.Correction/removal number: z-0023-2022.
Additional Manufacturer Narrative
Additional information: b6, b7, d8 fu1- missing information: g3 date- 27 apr 2023, g6 30day, h2.Device evaluation.Right knee was revised on (b)(6) 2023 due to a loose femoral component and recalled poly.The revision surgery was approximately 3 years, 9 months, after initial implant.Due to the recall the device will not be released by the hospital.No additional information is available.These devices are used for treatment not diagnosis.Correction to reported information from initial report: f6 & f8 & f10 should be blank h7& h9 should be blank, the femoral component not under recall.
Additional Manufacturer Narrative
H6 investigation: the revision reported in (b)(4) was likely the result of an insufficient bond between the femoral component and the bone and/or patient related conditions, which led to aseptic (non-infected) femoral loosening and pain.However, this cannot be confirmed as the devices were not available for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported was likely the result of the reported loss of range of motion and an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening.Failure of the cement used to secure the femoral component to the femoral bone, may have led to loosening at the cement-bone interface and/or cement-implant interface; however, this cannot be confirmed as the devices were not returned for evaluation.The reported prosthesis wear could not be confirmed from the provided images.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT PS CEM FEM PS CEM LEFT SZ 3
• 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: 16686905
• Report Number: 1038671-2023-00590
• Device Sequence Number: 7362332
• Product Code: JWH
• UDI-Device Identifier: 10885862314437
• UDI-Public: 10885862314437
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/15/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02-020-11-0230
• Device Catalogue Number: 02-020-11-0230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/13/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 03/13/2023; 05/10/2023; 04/14/2025
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 05/09/2023; 05/10/2023; 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2019
• 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
• Patient Age: 58 YR
• Patient Sex: Female