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

Model Number	TRULIANT PS CEM FEM PS CEM LEFT SZ 3.5
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377); Joint effusion (4849)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products: truliant tib imp ps insert sz 3.5 9mm (cat# 02-022-35-3509 / serial# (b)(6) - recall z-0023-2022).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately five years post initial left tka, the 48 y/o female patient complained of pain.The patient had a revision due to loose femur and recalled poly.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images and x-rays received.The devices are not available for evaluation due to recall hospital will not release.
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 pain, which was caused by an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening or due to the inclusion of the polyethylene in the packaging recall.The reason for the reported loosening cannot be confirmed as the devices were not returned for evaluation.Failure of the cement used to secure the femoral component to the femoral bone, may have lead to loosening at the cement-implant interface; however, this cannot be confirmed.Prosthesis wear of the tibial insert could not be confirmed from the images provided.The observed wear on the patella may have been caused by high contact stresses during knee flexion or third body wear, however, this cannot be confirmed.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 3.5
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: miguel soza
• MDR Report Key: 18812704
• Report Number: 1038671-2024-00354
• Device Sequence Number: 15586365
• Product Code: JWH
• UDI-Device Identifier: 10885862314444
• UDI-Public: 10885862314444
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TRULIANT PS CEM FEM PS CEM LEFT SZ 3.5
• Device Catalogue Number: 02-020-11-0235
• 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: 02/06/2024
• Supplement Date Received by Manufacturer: 04/18/2025
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female