MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 6 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-6009
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): 02-020-11-0260 - truliant ps cem fem ps cem left sz 6: (b)(6); 02-022-45-6060 - truliant tib fit tray cem sz 6f / 6t: (b)(6); 200-02-38 - three peg patella 38mm: (b)(6); 201-78-82 - collar fixation pin 2pk 40mm, quick release: (b)(6); 201-78-89 - 3" drill bit, mod.Hex 2 pack: (b)(6); 201-78-89 - 3" drill bit, mod.Hex 2 pack: (b)(6); 521-78-31 - threaded pin size 2.6 collarless 2pk: (b)(6).
Event or Problem Description
As reported by the exactech truliant knee clinical study, approximately 1 year post op initial left tka, this 72 y/o male patient was experiencing knee patellar clunk.Patient was having pain that has been non-responsive to conservative measures.The case report form indicates this event is not related to devices and definitely procedure.This event report was received through clinical data collection activities.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 6 9MM
• 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, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18419634
• Report Number: 1038671-2023-03077
• Device Sequence Number: 12805232
• Product Code: JWH
• UDI-Device Identifier: 10885862304704
• UDI-Public: 10885862304704
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 12/29/2023

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: 12/18/2025
• Device Catalogue Number: 02-022-35-6009
• 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: 12/07/2023
• Initial Report FDA Received Date: 12/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Race: White