MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 5 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-5011
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint effusion (4849)
Date of Event	02/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical products: 6156349, 02-020-11-0250 - truliant ps cem fem ps cem left sz 5.5823532, 02-022-35-5011 - truliant tib imp ps insert sz 5 11mm.6132300, 02-022-45-5040 - truliant tib fit tray cem sz 5f / 4t.5842277, 200-07-35 - advanced patella 35mm 3 peg implant.S038756, 521-78-36 - threaded pin size 5.1 collarless 2pk.
Event or Problem Description
As reported, approximately 3.5 years post op the initial left tka, this 60 y/o male patient was revised due to pain.Patient had a loose femur and recalled poly.No breakage of device or surgical delay.Patient was last known to be in stable condition following the event.No other patient information/medical history reported.X-ray & photo are attached.Product is not returning, due to recall hospital will not release implants.
Additional Manufacturer Narrative
These devices are used for treatment not diagnosis.
Event or Problem Description
Additional information via legal department: revision operative report of 27 feb 2023.Postoperative diagnoses: 1.Failed left total knee arthroplasty secondary to polyethylene wear.2.Aseptic femoral loosening.3.Medial compartment arthritis, right knee.Indications for procedure: the patient is a 60-year-old male who is status post a primary left total knee arthroplasty for osteoarthritis.He has had increasing effusions over the last couple of years with a negative infection workup.In addition, he has had increasing right knee pain with x-ray evidence of bone-on-bone medial compartment arthritis.He completed two injections into the knee with viscosupplementation.Procedure: there was hemosiderin staining in the synovium which was debrided.The patella was subluxed and found to be well fixed.The patella was then everted and the previous polyethylene insert was removed.There was evidence of polyethylene wear.At this point, the components were checked.The femoral component was easily disimpacted from the intact cement mantle on the femoral side.Tibial component was well fixed.The patient was awakened and taken to recovery room in stable condition.There were no complications.The patient was revised to exactech devices.
Additional Manufacturer Narrative
Section h10: h3: the revision reported was likely the result of an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening and pain.A contributing factor to the revision may have been inclusion of the implanted polyethylene component in the packaging recall.However, this cannot be confirmed as the devices were not available for evaluation.Section h11: the following sections have corrected information: h6: component code: 4755, part/component/sub-assembly term not applicable.
Additional Manufacturer Narrative
H6: investigation results - the revision reported was likely the result of polyethylene wear, femoral loosening, and pain as stated in the operative notes and experience report.However, the photographed tibial insert does not appear to show signs of wear that are inconsistent with implantation.The aseptic (non-infected) femoral loosening may have been the result of an insufficient bond between the femoral component and/or patient-related conditions.A contributing factor to the revision may have been inclusion of the implanted polyethylene component in the packaging recall.
Additional Manufacturer Narrative
(d10) concomitant device(s): (b)(6) 02-020-11-0250 - truliant ps cem fem ps cem left sz 5.(b)(6) 02-022-45-5040 - truliant tib fit tray cem sz 5f/4t.(b)(6) 200-07-35 - advanced patella 35mm 3 peg implant.(b)(6) 521-78-36 - threaded pin size 5.1 collarless 2pk.This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, g1, h6 clinical code, medical device problem code, component codes, type of investigation codes.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 5 11MM
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 16584618
• Report Number: 1038671-2023-00469
• Device Sequence Number: 14623028
• Product Code: JWH
• UDI-Device Identifier: 10885862304636
• UDI-Public: 10885862304636
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/19/2026

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: 02-022-35-5011
• 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: 02/27/2023
• Supplement Date Received by Manufacturer: 05/18/2023; 05/04/2023; 08/04/2023; 02/16/2026
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 05/18/2023; 06/16/2023; 08/09/2023; 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0023-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male