MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM RIGHT SZ 3; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT PS CEM FEM PS CEM RIGHT SZ 3
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	06/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately five years post initial right tka, the 67 y/o female patient came in due to the tibial insert recall.Patient had a revision due to recall and the femur was loose.Patient was revised from a size 3 femur and a recall tibial insert to a size 3 constrained femur with a ps size 15 mm tibial insert and a stem extension.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.X-rays and images received.The devices are not available for evaluation.
Additional Manufacturer Narrative
Section d10: concomitant products: truliant tib imp ps insert sz 3 11mm (cat#: 02-022-35-3011 / serial#; (b)(6).Tru stem ext 14mm x 25mm (cat#: 02-012-60-1425 / serial#: (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H3: 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.The extent and root cause of the femoral loosening and the prosthesis wear could not be determined as the devices were not returned for evaluation.
Additional Manufacturer Narrative
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.The extent and root cause of the femoral loosening and the prosthesis wear could not be determined as the devices were not returned for evaluation.H6: corrected health effect, component, and investigation clinical codes.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.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
It was reported via legal documentation that approximately 60 months after a right total knee replacement procedure, the patient underwent a revision procedure to address loosening.No further issues or complications were reported.No additional information is available.

• Brand Name: TRULIANT PS CEM FEM PS CEM RIGHT SZ 3
• 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: 17305544
• Report Number: 1038671-2023-01620
• Device Sequence Number: 7185298
• Product Code: JWH
• UDI-Device Identifier: 10885862314543
• UDI-Public: 10885862314543
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K170240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 03/11/2025

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 3
• Device Catalogue Number: 02-020-11-0330
• 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: 06/23/2023
• Supplement Date Received by Manufacturer: 04/04/2024; Not provided; 03/11/2025
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 04/23/2024; 01/16/2025; 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2018
• 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: THREE PEG PATELLA 35MM; TIBIAL STEM EXT. SCREW; TRULIANT TIB FIT TRAY CEM SZ 3F / 3T
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female