MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 2.5 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-2511
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	01/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation a patient had an initial left knee total arthroplasty on (b)(6) 2019 and then approximately 4 years 7 months later experienced a revision surgical procedure on 30 jan 2024.The patient complained of pain.Revision for loose femur and recalled poly.Polyethylene wear.The patient revised to exactech devices.Reported event is not related to breakage of a device and did not lead to surgical delay/prolongation.Patient was last known to be in stable condition following the event.The device will not be returned, the hospital will not release it.There is no other information available.
Additional Manufacturer Narrative
Initial legal complaint received 27 dec 2023, information received 30 jan 2024 that patient was revised on (b)(6) 2024.D10.Concomitants: 5920152 02-020-11-0225 - truliant ps cem fem ps cem left sz 2.5.5749079 02-022-45-2515 - truliant tib fit tray cem sz 2.5f / 1.5t.5757639 200-07-32 - advanced patella 32mm 3 peg implant.These devices are used for treatment not diagnosis.Pending investigation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Correction fields: b2, g, g2, h6-clinical code, component code, investigation codes.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c.The reason for the revision reported cannot be confirmed from the information provided but may be the result of femoral loosening or due to inclusion of the polyethylene in the packaging recall.The minor wear on the tibial insert was an incidental finding and likely was not the cause for the revision.Failure of the cement used to secure the femoral component to the femoral bone, may have lead to loosening at the cement-implant interface and/or cement-bone interface; however, this cannot be confirmed.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 2.5 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 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 18627219
• Report Number: 1038671-2024-00146
• Device Sequence Number: 8092511
• Product Code: JWH
• UDI-Device Identifier: 10885862304186
• UDI-Public: 10885862304186
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2025

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 Expiration Date: 05/01/2025
• Device Catalogue Number: 02-022-35-2511
• 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: 12/27/2023
• Supplement Date Received by Manufacturer: 03/10/2025; 10/14/2025
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 03/10/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2017
• 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
• 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: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 55 KG