MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM RIGHT SZ 4.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT PS CEM FEM PS CEM RIGHT SZ 4.5
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377); Implant Pain (4561); Joint effusion (4849)
Date of Event	03/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: truliant tib imp ps insert sz 4.5 10mm (cat# 02-022-35-4510/serial# (b)(4).As of note: "the explanted device truliant tib imp ps insert sz 4.5 10mm (cat# 02-022-35-4510 / serial# (b)(4) is part of a product recall and under z-0023-2022".Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately four years post initial right tka, the 58 y/o male patient complained of pain.Patient had 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.Photos and x-rays received.The device is not available for evaluation due to hospital will not release recall products.No other patient information/medical history reported.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the revision reported may have been the result of femoral loosening and patella wear.The femoral loosening may have been the result of an insufficient bond between the femoral component and the bone and patient-related conditions.However, this cannot be confirmed as the devices were not available for evaluation and the photographed tibial insert does not appear to show signs of wear/delamination that are inconsistent with being implanted.The most probable root cause associated with the reported event of ¿loosening - femoral¿ is associated with weakened integration of the femoral component at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.Furthermore, the most probable root cause associated with the event of ¿prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3/g4, h6.The following sections were corrected: h6.Mdr section codes updated/corrected: e, g.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
The revision reported may have been the result of femoral loosening and patella wear.The femoral loosening may have been the result of an insufficient bond between the femoral component and the bone and patient-related conditions.However, this cannot be confirmed as the devices were not available for evaluation and the photographed tibial insert does not appear to show signs of wear/delamination that are inconsistent with being implanted.H6: corrected component, and investigation clinical codes.

• Brand Name: TRULIANT PS CEM FEM PS CEM RIGHT SZ 4.5
• 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: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16668448
• Report Number: 1038671-2023-00571
• Device Sequence Number: 12245686
• Product Code: JWH
• UDI-Device Identifier: 10885862314574
• UDI-Public: 10885862314574
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/24/2025

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 RIGHT SZ 4.5
• Device Catalogue Number: 02-020-11-0345
• 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: 03/08/2023
• Supplement Date Received by Manufacturer: 07/05/2023; 02/28/2025; 04/24/2025
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 08/08/2023; 03/03/2025; 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2018
• 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: ADVANCED PATELLA 35MM 3 PEG IMPLANT; TRULIANT TIB FIT TRAY CEM SZ 4.5F/3.5T
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male