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

Catalog Number	02-020-11-0245
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	01/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitant devices: (b)(6), 02-022-45-4545 - truliant tib fit tray cem sz 4.5f/4.5t, (b)(6), 204-70-00 - tibial stem ext.Screw, (b)(6), 02-012-60-1425 - tru stem ext 14mm x 25mm, (b)(6), 02-020-11-0245 - truliant ps cem fem ps cem left sz 4.5, (b)(6), 200-02-35 - three peg patella 35mm.The product associated with the reported event is within the scope of recall z-0023-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
Legal case: as reported via legal documentation, this patient had left knee replacement on (b)(6) 2018.They underwent left knee revision on (b)(6) 2023, approximately 4 years 2 months after their initial implantation.Postoperative diagnosis: failed left total knee polyethylene due to premature wear and poly recall, as well as osteolysis of the left femoral component.There were well-fixed tibial and patellar components.There was a loose femoral component that was loose from the cement mantle.There was moderate polyethylene wear visible and palpable within the tibial polyethylene.There was also found to be polyethylene debris encapsulated within the synovium.The cement mantle was found to remain on the femur and there was no cement adherent to the back side of the femoral component.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.No device return anticipated due to this being a legal case.Ebi initial surgery attached.Historical record & smartsolve searched for sn/patient name with no results.No further information.
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.

• Brand Name: TRULIANT PS CEM FEM PS CEM LEFT SZ 4.5
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20698350
• Report Number: 1038671-2024-04409
• Device Sequence Number: 6488919
• Product Code: JWH
• UDI-Device Identifier: 10885862314468
• UDI-Public: 10885862314468
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• 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: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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: 02-020-11-0245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/19/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Supplement Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 03/20/2025
• Date Device Manufactured: 09/11/2018
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male