MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM RIGHT SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-020-11-0350
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Contracture (4528); Unspecified Musculoskeletal problem (4535)
Date of Event	02/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6) 02-022-35-5009 - truliant tib imp ps insert sz 5 9mm.(b)(6) 204-70-00 - tibial stem ext.Screw.(b)(6) 02-012-60-1440 - logic stem ext 14mm x 40mm.(b)(6) 02-022-45-5040 - truliant tib fit tray cem sz 5f / 4t.H10: multiple mdr reports were filed for this event.The revision reported was likely the result of prosthesis wear and an insufficient bond between the femoral component and the bone which led to aseptic (non-infected) femoral loosening.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.Failure of the cement used to secure the femoral component to the femoral bone likely led to loosening at the cement-implant interface; however, this cannot be confirmed as there were no details regarding cementing technique or environmental conditions provided.The extent and root cause of the prosthesis wear and the femoral loosening could not be determined as the devices were not returned for evaluation, and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
Report #2 of 2 for this event.It was reported the patient had a right total knee arthroplasty.Subsequently, two (2) years later the patient began to experience significant pain with the right knee, was unable to walk, pain with weightbearing and flexion contracture.As a result, the patient underwent a right knee revision procedure.A revision operative report was provided.Pre and post operative diagnosis' were right prosthetic flexion contracture and debonding of the femoral component.Intraoperatively, osteoporosis was observed.No obvious wear to the tibial insert but easily removed.The femoral canal cement was in tact, but the femoral component was completely debonded from the cement.The patient was revised to another manufacturer's knee system.The patient was then transferred to pacu in stable condition.Additionally, it was reported via legal documentation that the patient continues to experience significant pain and discomfort; gait impairment; poor balance; difficulty walking and bone loss.No additional information is available.

• Brand Name: TRULIANT PS CEM FEM PS CEM RIGHT SZ 5
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: katy priest ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 25224783
• Report Number: 1038671-2026-00625
• Device Sequence Number: 9997806
• Product Code: JWH
• UDI-Device Identifier: 10885862314581
• UDI-Public: 10885862314581
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2026

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 Catalogue Number: 02-020-11-0350
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 05/19/2026
• Date Device Manufactured: 03/05/2020
• 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 H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male