MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM LEFT SZ 1.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	02-020-11-0215
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Lack of Effect (4065)
Health Effect - Clinical Codes	Failure of Implant (1924); Loss of Range of Motion (2032); Scar Tissue (2060); Synovitis (2094); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10.Concomitants: (b)(6), 02-022-45-1515 - truliant tib fit tray cem sz 1.5f / 1.5t.(b)(6), 200-07-29 - advanced patella 29m 3 peg implant.(b)(6), 02-022-35-1509 - truliant tib imp ps insert sz 1.5, 9mm.
Event or Problem Description
As reported via legal documentation, this patient had a left total knee arthroplasty on (b)(6) 2018.They subsequently had left knee revision on (b)(6) 2022, approximately 3 years 11 months after their initial surgery.Postoperative diagnosis: failed left total knee arthroplasty secondary to aseptic loosening of the femoral component and a recalled tibial insert.Radiographs did not show any obvious signs of wear or loosening.The patient had significant scar tissue within the joint and some synovitis, but no signs of infection or purulence.The patellar button was found to be well fixed and in good condition.Upon removal of the insert, there were no signs of wear or damage to the insert.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, loss of range of motion, 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 1.5
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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: kate jacobson ; 3523782617
• MDR Report Key: 17130934
• Report Number: 1038671-2023-01347
• Device Sequence Number: 18000722
• Product Code: JWH
• UDI-Device Identifier: 10885862314406
• UDI-Public: 10885862314406
• 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: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2024

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
• Device Expiration Date: 06/23/2025
• Device Model Number: 02-020-11-0215
• Device Catalogue Number: 02-020-11-0215
• 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: 05/22/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 12/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2017
• 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 H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Unknown