MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM RIGHT SZ 6; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number TRULIANT PS CEM FEM PS CEM RIGHT SZ 6

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 01/17/2023

Event Type  Injury  

Manufacturer Narrative

Truliant tib imp ps insert sz 6 11mm (cat# 02-022-35-6011 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported approximately three years post initial right side tka, the 72 y/o male patient complained of pain.Patient had a revision due to loose femur and recalled insert.Patient was revised to exactech devices.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 image received.The device is not available for evaluation due to recall hospital will not release implants.

• Brand Name: TRULIANT PS CEM FEM PS CEM RIGHT SZ 6
• Type of Device: 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 ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16264639
• MDR Text Key: 308377908
• Report Number: 1038671-2023-00080
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862314598
• UDI-Public: 10885862314598
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170240
• 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: 01/30/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: TRULIANT PS CEM FEM PS CEM RIGHT SZ 6
• Device Catalogue Number: 02-020-11-0360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/07/2019
• 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: ADVANCED PATELLA 35MM 3 PEG IMPLANT.; FLUTED HEADLESS PIN 3.0" SQUARE HEAD.; TRULIANT TIB FIT TRAY CEM SZ 6F / 5T.
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male