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

Catalog Number	02-020-11-0250
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Joint effusion (4849)
Date of Event	10/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 02-020-11-0250, (b)(6) -truliant ps cem fem ps cem left sz 5 02-022-45-5050, (b)(6) -truliant tib fit tray cem sz 5f/5t 200-02-41, (b)(6) -three peg patella 41mm 201-78-18, (b)(6) -holding pin headless no ribs w/30 deg pt 4 pack.
Event or Problem Description
It was reported via legal notifications and other sources, that a male patient, who was initially implanted on the left knee on (b)(6) 2018, was seen in the clinic and they are having symptoms/pain/effusions, indicating a revision surgery is necessary.A revision ltka had been scheduled for (b)(6) 2022.The revision occurred.Pre-op/post-op diagnoses: failed left tka secondary to aseptic femoral loosening.Indications: increasing effusions and weightbearing pain with clinical evidence of a femoral loosening.Procedure: the patella was well fixed, left in place.Previous 12 mm insert was removed.The femoral was disimpacted from intact cement mantle.Tibia was well fixed, left in place.Previous 12mm insert was removed.The femoral was disimpacted.Tibia was well fixed and left in place.The patient was revised to exactech devices.No complications.Patient was taken to recovery in stable condition.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported in cannot be confirmed from the information provided but may be the result of prosthesis wear and femoral loosening or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available 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.

• Brand Name: TRULIANT PS CEM FEM PS CEM LEFT 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 66 court; gainesville 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville 32653 ; 3525541928
• MDR Report Key: 20444017
• Report Number: 1038671-2024-03971
• Device Sequence Number: 12761236
• Product Code: JWH
• UDI-Device Identifier: 10885862314475
• UDI-Public: 10885862314475
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

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 Catalogue Number: 02-020-11-0250
• 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: 08/19/2022
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2017
• 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: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male