MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB FIT TRAY CEM SZ 4F / 3T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-45-4030
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Pain (1994); Inadequate Osseointegration (2646); Joint Laxity (4526); Medical device site infection (4845)
Date of Event	09/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant devices: 6264444 - 02-010-04-0240 - logic cr femoral por, left, sz 4; 4141935 - 02-012-51-4013 - logic tib insert impl crc, sz 4, 13mm; 6529350 - 200-02-32 - three peg patella 32mm.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported via legal documentation that a patient had an initial left total knee arthroplasty and then approximately 1 year, 9 months later, the patient experienced a revision surgical procedure.The patient was revised to a competitor's devices.Revision operative report states- failed tka secondary septic loosening.X-rays demonstrated loosening of tibial as well as patellar component.Aspirated knee, it was significant for red blood cells as well as 12,000 white blood cells with 100% neutrophil differential- nothing grew from the aspiration.Patellar component was completely loose.Removed any remaining cement.Femoral component was grossly loose.Removed the tibial component, it was grossly loose.No apparent complications noted.There is no clinical/patient medical information provided.No device return anticipated due to this being a legal case and no other information is available at this time.
Additional Manufacturer Narrative
The cause of the patient¿s infection/septic loosening and subsequent revision cannot be conclusively determined.However, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.There is no clinical/patient medical information provided.These devices are used for treatment not diagnosis.B3: corrected.H6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: TRULIANT TIB FIT TRAY CEM SZ 4F / 3T
• 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; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21143383
• Report Number: 1038671-2025-00213
• Device Sequence Number: 21147850
• Product Code: JWH
• UDI-Device Identifier: 10885862305879
• UDI-Public: 10885862305879
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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 Catalogue Number: 02-022-45-4030
• 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: 02/29/2024
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 06/04/2025
• Date Device Manufactured: 02/14/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female