MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 2 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 200-07-26

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Failure of Implant (1924)

Event Date 08/15/2023

Event Type  Injury  

Manufacturer Narrative

Section h10: (h3) pending evaluation; (d10) concomitant device(s): 7147118 02-020-11-0320 - truliant ps cem fem ps cem right sz 2; 6778800 02-022-45-2015 - truliant tray, cem sz 2f/1.5t; a223511 201-78-15 - holding pin mini sharp point 4 pk; 7309028 201-78-81 - 3" trocar, mod.Hex 2pk; 7309050 201-78-81 - 3" trocar, mod.Hex 2pk; s428025 521-78-23 - threaded pin size 2.3 collared 2pk; 7147118 02-022-35-2011 - truliant tib imp ps insert sz 2 11mm.

Event Description

It was reported that this 74 y/o female patient's right knee was revised approximately 3 month post op.The patient had an issue with the patella tracking, so the surgeon was going to revise the patella.During surgery he found nothing wrong with the patella implant, excised more tissue around the patella and downsized the 9mm poly.Patient was last known to be in stable condition following the event.Unable to obtain photos/x-rays.Product not returning - the hospital keeps explants.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 2 11MM
• Type of Device: 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: kate jacobson ; 3523771140
• MDR Report Key: 17715824
• MDR Text Key: 323041107
• Report Number: 1038671-2023-02215
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862314260
• UDI-Public: 10885862314260
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160484
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2024
• Device Catalogue Number: 200-07-26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/12/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Age: 74 YR
• Patient Sex: Female