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

Catalog Number	02-020-11-0230
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Osteolysis (2377); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 5584703 02-012-60-1425 - tru stem ext 14mm x 25mm.5576627 02-022-45-3030 - truliant tib fit tray cem sz 3f / 3t.5594848 200-02-32 - three peg patella 32mm.5580052 204-70-00 - tibial stem ext.Screw.M001745 02-022-35-3011 - truliant tib imp ps insert sz 3 11mm.Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a left knee replacement on (b)(6) 2018.Approximately 4 years and 6 months after the initial procedure the patient had a left knee revision on (b)(6) 2023.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report on (b)(6) 2023.Diagnosis: failed left total knee due to premature poly wear and osteolysis.There was found to be a clean wound with clear synovial joint fluid.There was a grossly loose femoral component with no adherent back side cement.There was a severe amount of osteolysis on the distal femur.There was a partially loose tibial component with a moderate amount of proximal tibial osteolysis.There was a well-fixed patellar component.There was a severe amount of extraneous synovial tissue and complete synovectomy was performed.The patient was awakened and transferred to recovery in stable condition.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of femoral loosening, prosthesis wear, and tibial loosening.The reported femoral loosening, prosthesis wear, and tibial loosening could not be confirmed.The tibial insert involved in this case is not within the scope of the polyethylene 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.D4: corrected.H6: corrected health effect, component, and investigation clinical codes.

• Brand Name: TRULIANT PS CEM FEM PS CEM LEFT SZ 3
• 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 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; gainesville 32653
• MDR Report Key: 18031060
• Report Number: 1038671-2023-02629
• Device Sequence Number: 6849440
• Product Code: JWH
• UDI-Device Identifier: 10885862314437
• UDI-Public: 10885862314437
• 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
• 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): 01/14/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 02-020-11-0230
• 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: 08/18/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 01/14/2025
• Date Device Manufactured: 09/04/2018
• 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: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female