MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS POR FEM PS POR RIGHT SZ 2.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT PS POR FEM PS POR RIGHT SZ 2.5
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant devices: truliant tib imp ps insert sz 2.5 10 mm (cat# 02-022-35-2510 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 14 months post rtka, this (b)(6) female patient had a revision due to right knee failed press fit femoral component that showed loosening along the anterior of the implant.Patient was downsized from 2.5 to a 2 condylar constrained knee with a 14x80 stem.Patient was last known to be in stable condition following the event.The device will be returned.
Additional Manufacturer Narrative
After further review of additional information received the following sections a4, b7, d9, d10, g3, g7, h2, h3 and h6 have been updated accordingly.Section d10: concomitant devices: truliant tib imp ps insert sz 2.5 10mm (cat# 02-022-35-2510 / serial#(b)(6)).Tibial tray (cat# 02-022-55-2525).Patella (cat# 200-02-32).(h3) the evaluation noted that revision reported was likely the result of an insufficient bond between the femoral component and bone, which led to aseptic (non-infected) femoral loosening.The most probable root cause associated with the reported event of "loosening - femoral" is associated with weakened integration of the femoral component at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.
Additional Manufacturer Narrative
The revision reported was likely the result of an insufficient bond between the femoral component and bone, which led to aseptic (non-infected) femoral loosening.

• Brand Name: TRULIANT PS POR FEM PS POR RIGHT SZ 2.5
• 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 sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 12361271
• Report Number: 1038671-2021-00413
• Device Sequence Number: 17099150
• Product Code: JWH
• UDI-Device Identifier: 10885862314888
• UDI-Public: 10885862314888
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K181794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2024

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 PS POR FEM PS POR RIGHT SZ 2.5
• Device Catalogue Number: 02-020-12-0325
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 09/30/2021; 02/12/2024
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 10/26/2021; 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2018
• 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
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 70 KG