MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 5 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	02-022-35-5013
Medical Device Problem Codes	Unstable (1667); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377); Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	06/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
This 79 year old, male patient had a right knee tka on (b)(6) 2019.The patient complained of pain and was revised on (b)(6) 2022 due to the current insert not being fully locked in and becoming disassociated.The surgeon revised the patient to a size 5/19mm.There is no reported breakage of the device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Pending device return and evaluation.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of the not fully seating the tibial insert in the tibial tray at the time of implantation, imbalanced flexion-extension gaps, instability based on the surgeon¿s decision to upsize the tibial insert from a 13mm to a 19mm, patient-related conditions, an unreported post traumatic event, or any combination of these possibilities, which led to tibial insert disassociation.H7: z-0023-2022.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of the not fully seating the tibial insert in the tibial tray at the time of implantation, imbalanced flexion-extension gaps, instability based on the surgeon¿s decision to upsize the tibial insert from a 13mm to a 19mm, osteolysis, patient-related conditions, an unreported post traumatic event, or any combination of these possibilities, which led to tibial insert disassociation.
Event or Problem Description
As reported, approximately three years post patient's right knee revision, the 75 y/o male patient intraoperative findings revealed a moderate amount of noninfected appearing joint fluid.There was synovial hypertrophy consistent with polyethylene wear.The polyethylene liner was dislodged from the tibial locking mechanism.There was severe backside wear of the polyethylene liner without significant wear on the articular surface of the polyethylene.Femoral component was well fixed and in good position as was the patellar component.The tibial component had a osteolytic lesion under the medial aspect of the tibia encompassing about 20 to 25% of the supportive surface of the implant.The tibial component was solidly fixed and retained.
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: a, b, c, d, e, f, g.The revision reported was likely the result of not fully seating the tibial insert in the tibial tray at the time of implantation, instability based on the surgeon¿s decision to upsize the tibial insert from a 13mm to a 19mm, imbalanced flexion-extension gaps, patient-related conditions, an unreported post traumatic event, osteolysis, or any combination of these possibilities, which led to tibial insert disassociation.Additional reasons for the reported revision may be prosthesis wear and inclusion of the polyethylene in the packaging recall.However, the reported prosthesis wear could not be confirmed.Potential contributions of user and patient-related considerations to the event could not be assessed.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 5 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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 ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15051707
• Report Number: 1038671-2022-00808
• Device Sequence Number: 14619592
• Product Code: JWH
• UDI-Device Identifier: 10885862304650
• UDI-Public: 10885862304650
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• 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
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/29/2025

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 Expiration Date: 07/11/2026
• Device Model Number: 02-022-35-5013
• Device Catalogue Number: 02-022-35-5013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/30/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2022
• Supplement Date Received by Manufacturer: 01/06/2023; 01/24/2024; 01/28/2025
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 01/24/2023; 02/09/2024; 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male