MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 3.5, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT TIB IMP PSC INSERT SZ 3.5, 13MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a right knee revision.Unstable knee and posterior poly wear were indicated.The 13psc was swapped to 17psc.Initial implant date is unknown.The patient was last known to be in stable condition following the event.The explanted implants are not available for return as the hospital is keeping them.
Additional Manufacturer Narrative
Hospital is keeping the devices.Concomitants medical devices: 02-012-60-1440 - logic stem ext 14mm x 40mm 6692318, 02-020-11-0335 - truliant ps cem fem ps cem right sz 3.5 6574008, 02-022-45-3525 - truliant tib fit tray cem sz 3.5f / 2.5t 6576806, 200-07-32 - advanced patella 32mm 3 peg implant 6737274, 201-78-15 - holding pin mini sharp point 4 pk 6800956, 201-78-81 - 3" trocar, mod.Hex 2pk 6743637, 204-70-00 - tibial stem ext.Screw 6827100.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
There were no device breakages or surgical delays.Patient was initially implanted on (b)(6), 2021, and the revision was approximately 1 year 4 months post the initial implant procedure.
Additional Manufacturer Narrative
After review of additional information received the following sections, have been updated accordingly: b5, h6, h7, h9.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d6a (remove erroneous implant date from initial report) h6: medical device problem code, component code, investigation conclusion the revision reported was likely the result of joint instability, which allowed for posterior wear of the tibial insert.However, this cannot be confirmed because the revised component was not returned to exactech for evaluation and no images or radiographs were provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT TIB IMP PSC INSERT SZ 3.5, 13MM
• 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15216238
• Report Number: 1038671-2022-00912
• Device Sequence Number: 20413698
• Product Code: JWH
• UDI-Device Identifier: 10885862305213
• UDI-Public: 10885862305213
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/19/2025

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 Model Number: TRULIANT TIB IMP PSC INSERT SZ 3.5, 13MM
• Device Catalogue Number: 02-022-44-3513
• 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: 07/13/2022
• Supplement Date Received by Manufacturer: 04/27/2023; 11/17/2025
• Initial Report FDA Received Date: 08/12/2022
• Supplement Report FDA Received Date: 05/17/2023; 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2019
• 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
• 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: SEE H10; SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown