MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM LEFT SZ 3.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	02-020-11-0235
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Swelling/ Edema (4577)
Date of Event	06/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation a female patient had an initial left total knee arthroplasty on (b)(6) 2021 and then approximately 11 months later underwent a revision surgery for loosening.Revision operative report of(b)(6) 2022 for failed left total knee arthroplasty secondary to aseptic loosening of the femoral component and recalled polyethylene insert.The patient had progressive pain with activities and swelling, which continued to get worse.Radiographs showed a developing radiolucency under the femoral component.Negative for infection.1ml of inflammatory fluid drawn, there was no purulence or sign of infection.The patellar button was in good condition and well fixed, it was retained.The tibial insert was removed and did not show signs of delamination or wear.The femur disimpacted without difficulty.Sterile dressings were applied, the patient was awakened and transferred to the recovery room in stable condition.There is no other patient demographic or medical history available.The implant was kept for chain of custody.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Pending investigation.D10.Concomitants: 5831787 02-022-35-3509 - truliant tib imp ps insert sz 3.5 9mm.6776151 02-022-45-3525 - truliant tib fit tray cem sz 3.5f / 2.5t.6965372 200-07-32 - advanced patella 32mm 3 peg implant.
Additional Manufacturer Narrative
H10.Updated/additional information ¿ d5.G1.G2.G4.H6.The revision reported was likely the result of an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) loosening.A contributing factor may have been the patient related conditions detailed above.However, this cannot be confirmed as the devices were not returned for evaluation.

• Brand Name: TRULIANT PS CEM FEM PS CEM LEFT SZ 3.5
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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: julia goldberg ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523782617
• MDR Report Key: 16885794
• Report Number: 1038671-2023-00923
• Device Sequence Number: 6312249
• Product Code: JWH
• 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: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2026

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: 02-020-11-0235
• Device Catalogue Number: 02-020-11-0235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2023
• Supplement Date Received by Manufacturer: 02/23/2024; 09/29/2026
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 05/01/2024; 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female