MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT POR TIB TRAY SIZE 4.5F/3.5T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT POR TIB TRAY SIZE 4.5F/3.5T
Medical Device Problem Codes	Loss of Osseointegration (2408); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646)
Date of Event	10/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant products: truliant ps por fem ps por right sz 4.5 (cat# 02-020-12-0345 / serial# (b)(4)); truliant tib imp ps insert sz 4.5 9mm (cat# 02-022-35-4509 / serial# (b)(4)); advanced patella 32mm 3 peg implant (cat# 200-07-32 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 1.5 years post initial tka, the 64 y/o female patient had pain starting a few weeks after surgery.Patient is dissatisfied with implant function.Tibia was loose with only fibrous ingrowth.Femur also had minimal bone ingrowth.There was no breakage of the device.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain photos and x-rays.The devices are not available for evaluation due to recall hospital will not release.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the revision reported may have been the result of an insufficient bond between the implants and the bone, poor bone quality, patient-related conditions, or any combination of these possibilities, which led to aseptic (non-infected) loosening and pain.However, this cannot be confirmed as the devices were not available for evaluation and pre-revision radiographs were unable to be obtained.The most probable root cause associated with the reported event of ¿loosening¿ is associated with weakened integration of the device at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.
Additional Manufacturer Narrative
The revision reported may have been the result of an insufficient bond between the implants and the bone, poor bone quality, patient-related conditions, or any combination of these possibilities, which led to aseptic (non-infected) loosening and pain.However, this cannot be confirmed as the devices were not available for evaluation and pre-revision radiographs were unable to be obtained.This follow-up report is being submitted to relay corrected information.The following sections were corrected: b2, b5, g1, g4, h4, h6: clinical code, medical device problem code, component code, investigation findings and investigation conclusions.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
As reported, approximately 1.5 years post initial tka, the patient had pain starting a few weeks after surgery.Patient is dissatisfied with implant function.Tibia was loose with only fibrous ingrowth.Femur also had minimal bone ingrowth.There was no breakage of the device.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain photos and x-rays.The devices are not available for evaluation due to recall hospital will not release.

• Brand Name: TRULIANT POR TIB TRAY SIZE 4.5F/3.5T
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15666313
• Report Number: 1038671-2022-01346
• Device Sequence Number: 12548174
• Product Code: JWH
• UDI-Device Identifier: 10885862317216
• UDI-Public: 10885862317216
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K182346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2026

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 Model Number: TRULIANT POR TIB TRAY SIZE 4.5F/3.5T
• Device Catalogue Number: 02-022-55-4535
• 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: 10/06/2022
• Supplement Date Received by Manufacturer: 02/03/2023; 02/21/2026
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 02/21/2023; 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2019
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female