MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM LEFT SZ 2; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-020-11-0220
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 45 months after a total knee replacement procedure, the patient underwent a revision procedure to address loosening.Revision surgery operative notes were provided.Patient left the operating room in stable condition.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
1038671-2022-01635 d10: 02-012-60-1425 - 5626824 - logic stem ext 14mm x 25mm 02-022-35-2009 - 5047841 - truliant tib imp ps insert sz 2 9mm 02-022-45-2020 - 4750300 - truliant tib fit tray cem sz 2f / 2t 200-07-32 - 5724067 - advanced patella 32mm 3 peg implant 204-70-00 - 5721095 - tibial stem ext.Screw multiple mdr reports were filed for this event, please see associated reports: 1038671-2022-01635.The femoral loosening reported is most likely the result of either a weakened biologic integration of the femoral component at the bone-implant interface or mechanical loss of fixation at the cement-implant interface.However, the failure cannot be confirmed as the device was not returned for investigation, pre-revision x-rays were unable to be obtained, and potential contributions from the type of cement used, cementing technique, or environmental conditions in the operating room at the time of implantation cannot be determined from the provided information.Patient-related conditions and/or inclusion of the implanted polyethylene in the packaging recall may also have been contributing factors to the revision.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3/g4, h6 the following sections were corrected: h6 mdr section codes updated/corrected: b the femoral loosening reported is most likely the result of either a weakened biologic integration of the femoral component at the bone-implant interface or mechanical loss of fixation at the cement-implant interface.However, the failure cannot be confirmed as the device was not returned for investigation, pre-revision x-rays were unable to be obtained, and potential contributions from the type of cement used, cementing technique, or environmental conditions in the operating room at the time of implantation cannot be determined from the provided information.Patient-related conditions and/or inclusion of the implanted polyethylene in the packaging recall may also have been contributing factors to the revision.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 2
• 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
• MDR Report Key: 21217455
• Report Number: 1038671-2025-00352
• Device Sequence Number: 14322634
• Product Code: JWH
• UDI-Device Identifier: 10885862314413
• UDI-Public: 10885862314413
• 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: 2019
• 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): 02/06/2025

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: 02-020-11-0220
• 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: 12/08/2022
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 02/06/2025
• Date Device Manufactured: 05/03/2017
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 121 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White