MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CR INS STD SZ 4, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT TIB IMP CR INS STD SZ 4, 11MM
Medical Device Problem Codes	Mechanical Problem (1384); Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Loss of Range of Motion (2032); Anxiety (2328); Joint Laxity (4526); Implant Pain (4561)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the surgeon had a female patient that came in with a small non displaced distal femur fracture on the medial side of the femur that had a truliant total right knee implanted on (b)(6) 2021.The surgeon said the patient knew she was part of the poly recall and stated she fell because her knee was unstable "because of the recall".During surgery a competitor's retrograde nail was used to repair the fracture.The total knee components were will fixed and the poly insert was removed.There were no signs of wear on the poly and it had no noticeable oxidation or delamination.A new activit-e sz 4, 12mm poly was inserted and implanted.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images of the liner were taken.Photos/x-rays received.The device is not available for evaluation due to poly was kept after case concluded.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
D10 concomitants: 6349996 - 02-020-13-0340 - truliant cr cem fem cr cem right sz 4.5639693 - 02-022-45-4040 - truliant tib fit tray cem sz 4f / 4t.M007912 - 02-022-47-4011 - truliant tib imp cr ins std sz 4, 11mm.7031880 - 200-07-32 - advanced patella 32mm 3 peg implant.H6: corrected the following: health effect - clinical code, impact code, device problem code, component code, type of investigation, investigation findings, investigation conclusions.

• Brand Name: TRULIANT TIB IMP CR INS STD SZ 4, 11MM
• 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 ; gainesville 32653
• MDR Report Key: 19169045
• Report Number: 1038671-2024-00956
• Device Sequence Number: 7855700
• Product Code: JWH
• UDI-Device Identifier: 10885862306487
• UDI-Public: 10885862306487
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2025

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 Expiration Date: 08/16/2026
• Device Model Number: TRULIANT TIB IMP CR INS STD SZ 4, 11MM
• Device Catalogue Number: 02-022-47-4011
• 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: 03/18/2024
• Supplement Date Received by Manufacturer: Not provided; 08/01/2025
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 10/10/2024; 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2018
• 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
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ADVANCED PATELLA 32MM 3 PEG IMPLANT; SEE H11; TRULIANT CR CEM FEM CR CEM RIGHT SZ 4; TRULIANT TIB FIT TRAY CEM SZ 4F/4T; TRULIANT TIB IMP CR INS STD SZ 4, 11 MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female