MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM RIGHT SZ 2.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-020-11-0325
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Aseptic loosening (4883)
Date of Event	08/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical products: 02-012-60-1425, 6588070- logic stem ext 14mm x 25mm; 02-022-35-2509, s054602- truliant tib imp ps insert sz 2.5 9mm; 02-022-45-2525, 6577301 - truliant tib fit tray cem sz 2.5f / 2.5t; 200-07-32, 6771931- advanced patella 32mm 3 peg implant; 204-70-00, 6580135 - tibial stem ext.Screw.
Event or Problem Description
As reported, approximately 1.5 years post op the initial right tka, this 52 y/o female patient was revised due to a loose femur.Patient complained of pain.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Section h10: (h3) 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.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 corrected information.The following sections were corrected: b1, b2, d8, g2, h6 (clinical codes, medical device problem code, component code and investigation findings.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
H11: no device was returned for evaluation; photographs of the device were provided; however, the reported event was unable to be confirmed.The review identified the discoloration of the underside of the femoral component appears consistent with exposure to bone cement.The absence of bone cement adhesion was noted on the underside of the femoral component.This can indicate femoral loosening, which is consistent with the reported event; however, the reported femoral loosening cannot be confirmed as serial radiography was not provided.The red discoloration on the devices appears consistent with biological remnants.Overall, the tibial insert appears unremarkable for an implanted component.Operative notes and/or medical records were not provided for review of usage/ technique.A review of manufacturing data was performed and no discrepancies were found.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, may have been the result of an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening and inclusion of their tibial insert in the polyethylene packaging recall.Based on length of implantation, the reason for revision appears unlikely to be secondary to prosthesis wear.However, the reported prosthesis wear and loosening could not be confirmed and potential contributions of user- or patient-related considerations to the event could not be assessed as radiographs and relevant clinical information were not provided and the devices were not available for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6.

• Brand Name: TRULIANT PS CEM FEM PS CEM RIGHT SZ 2.5
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15326570
• Report Number: 1038671-2022-00982
• Device Sequence Number: 6484416
• Product Code: JWH
• UDI-Device Identifier: 10885862314536
• UDI-Public: 10885862314536
• 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: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/06/2026

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: 02-020-11-0325
• Device Catalogue Number: 02-020-11-0325
• 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: 08/11/2022
• Supplement Date Received by Manufacturer: 02/23/2023; 01/09/2026; 03/02/2026; 03/02/2026
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 03/17/2023; 01/14/2026; 03/06/2026; 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2020
• 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 H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Female