MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 4, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	ADVANCED PATELLA 32MM 3 PEG IMPLANT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Implant Pain (4561)
Date of Event	01/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately five years post initial tka, the patient was revised due to patella pain.A partial patellectomy was performed and new poly of same size was implanted.There was no issues with surgery.Photos and x-rays received.The devices are not available for evaluation.
Additional Manufacturer Narrative
Section d10: concomitant products - truliant tib imp psc insert sz 4, 13mm (cat# 02-022-44-4013 / serial# (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 following sections were updated/corrected: d1, d4, g4, h4, h6.Mdr section codes updated/corrected: b, c, d, e, g.The reason for the clinical symptom of pain reported cannot be conclusively determined and the event cannot be confirmed.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 4, 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: miguel soza
• MDR Report Key: 18650940
• Report Number: 1038671-2024-00159
• Device Sequence Number: 12526586
• Product Code: JWH
• UDI-Device Identifier: 10885862305305
• UDI-Public: 10885862305305
• 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
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2025

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: 04/30/2026
• Device Model Number: ADVANCED PATELLA 32MM 3 PEG IMPLANT
• Device Catalogue Number: 02-022-44-4013
• 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: 01/09/2024
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2018
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GPS IMPLANT KIT V2.; HOLDING PIN MINI SHARP POINT 4 PK.; THREADED PIN SIZE 2.3 COLLARED 2PK.; THREADED PIN SIZE 2.3 COLLARED 2PK.; THREADED PIN SIZE 3.0 COLLARLESS 2PK.; THREADED PIN SIZE 3.0 COLLARLESS 2PK.; THREADED PIN SIZE 5.1 COLLARLESS 2PK.; TRU TIB AUG 1/2 SIZE 4, 5MM.; TRU TIB AUG 1/2 SIZE 4, 5MM.; TRULIANT PS CEM FEM PS CEM LEFT.; TRULIANT TIB FIT TRAY CEM SZ 4F / 4T.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown