MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 5 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT TIB IMP PS INSERT SZ 5 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	10/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 4.5 years post initial right tka, upon removal of the tibial liner insert, the surgeons noticed that there was some back poly wear.Also, the surgeon removed all; there is a steel lysis on the lateral side with a significant amount of bone lost posteriorly.The patient was revised to a constrained right size 5 femur with a 10 mm augment lateral posteriorly with an 18 x 120 stem, h32 medium cone in a 2° coupler.Size 15 mm constrained liner.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.X-ray and images received.
Additional Manufacturer Narrative
Section d10: concomitant products.Truliant tib fit tray cem sz 5f / 5t cat# 02-022-45-5050 / serial# (b)(6).Truliant ps cem fem ps cem right sz 5 cat# 02-020-11-0350 / serial# (b)(6).Tibial stem ext.Screw cat# 204-70-00 / serial# (b)(6).Tru stem ext 14mm x 25mm (cat# 02-012-60-1425 / (b)(6) - three peg patella 38mm (at# 200-02-38 / serial# (b)(6).3" trocar, hex 2pk cat# 201-78-80 / (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and relevant clinical information were not 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 PS INSERT SZ 5 9MM
• 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
• MDR Report Key: 18117460
• Report Number: 1038671-2023-02748
• Device Sequence Number: 15355771
• Product Code: JWH
• UDI-Device Identifier: 10885862304612
• UDI-Public: 10885862304612
• 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: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2025

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 Expiration Date: 02/08/2025
• Device Model Number: TRULIANT TIB IMP PS INSERT SZ 5 9MM
• Device Catalogue Number: 02-022-35-5009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/18/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 11/12/2023
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male