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 Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Osteolysis (2377)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient's right knee was revised.Tibia construct was loose.Patient was revised to a 4f/3t tibia component with 10mm tibia augments, 2mm offset, 16 x 80mm splined stem and a 4x17mm ps insert.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of tibial loosening.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and relevant clinical information were not provided.D4: corrected d10: concomitant devices (b)(6), 02-010-06-0340 - tru cc femoral size 4 right (b)(6), 02-010-06-0541 - tru post.Aug.Size 4, 5mm (b)(6), 02-012-50-3011 - tru tib aug 1/2 size 3, 5mm (b)(6), 02-012-50-3011 - tru tib aug 1/2 size 3, 5mm (b)(6), 02-012-60-1440 - tru stem ext 14mm x 40mm (b)(6), 02-012-61-4000 - tru offset stem ext coupler, 4mm (b)(6), 02-012-64-1480 - tru fluted stm ext 14mm x 80mm blast (b)(6), 02-022-35-4015 - truliant tib imp ps insert sz 4 15mm (b)(6), 200-02-35 - three peg patella 35mm (b)(6), 201-78-15 - holding pin mini sharp point 4 pk (b)(6), 203-96-64 - sawblades ez1913.M62 90x19, 1.27mm strkr5/6/7 (b)(6), 208-05-04 - cc distal fem augment sz 4, 5mm (b)(6), 208-05-04 - cc distal fem augment sz 4, 5mm (b)(6), 521-78-23 - threaded pin size 2.3 collared 2pk (b)(6), 521-78-31 - threaded pin size 2.6 collarless 2pk g4: corrected h6: corrected 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21459442
• Report Number: 1038671-2025-01205
• Device Sequence Number: 18121078
• Product Code: JWH
• UDI-Device Identifier: 10885862305879
• UDI-Public: 10885862305879
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2025

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: 02/03/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 07/28/2025
• Date Device Manufactured: 12/05/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male