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 Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 1.5 years post initial left side tka, the 54 y/o male patient complained of pain.Patient due to recall surgeon used competitors implants for revision.There was no breakage of a device or surgical delay/prolongation.Image received.Sales rep was unable to obtain.The device is not available for evaluation due to recall hospital will not release.
Additional Manufacturer Narrative
As reported, approximately 1.5 years post initial left side tka, the 54 y/o male patient complained of pain.Patient due to recall surgeon used competitors implants for revision.There was no breakage of a device or surgical delay/prolongation.Image received.Sales rep was unable to obtain.The device is not available for evaluation due to recall hospital will not release.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition and activity.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
(d10) concomitants: serial #: (b)(6), category #: 02-022-45-5040 - truliant tib fit tray cem sz 5f / 4t, serial #: (b)(6), category #: 200-07-35 - advanced patella 35mm 3 peg implant, serial #: (b)(6), category #: 02-020-11-0250 - truliant ps cem fem ps cem left sz 5, this follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d8, d10, g1, h2, h6: medical device problem code, component code, investigation conclusions.Should additional relevant information be obtained, a follow-up mdr will be submitted 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: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16264445
• Report Number: 1038671-2023-00078
• Device Sequence Number: 4402987
• Product Code: JWH
• UDI-Device Identifier: 10885862304612
• UDI-Public: 10885862304612
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: 2023
• Serviced by Third Party (Y/N): N
• 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): 02/16/2026

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 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2023
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2020
• 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 H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male