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

Model Number	TRULIANT PS POR FEM PS POR LEFT SZ 2.5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: truliant tib imp ps insert sz 2.5 10mm (cat # 02-022-35-2510 / serial # (b)(4)), truliant por tib tray size 2.5f/1.5t (cat # 02-022-55-2515 / serial # (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, a (b)(6), female patient had a revision due to instability of the knee.This is a well fixated porous femur and tibia less than a year old.Surgeon removed the femoral and tibial porous components.Patient revised to a size 2 condylar constrained femur and he size 2f/1t truliant tibial fit tray with a 15 mm condylar constrained insert.There was no breakage to the device.There was no surgical delay/ prolongation.Patient was last known to be in stable condition following the event.The devices will be return.
Additional Manufacturer Narrative
After further review of additional information received the following sections d4, d9, g3, g6, h2, h3, h4 and h6 have been updated accordingly.As reported, a 59 years old, female patient had a revision due to instability of the knee.This is a well fixated porous femur and tibia less than a year old.Surgeon removed the femoral and tibial porous components.Patient revised to a size 2 condylar constrained femur and he size 2f/1t truliant tibial fit tray with a 15 mm condylar constrained insert.There was no breakage to the device.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.The devices will be return.Upon review of all available information, there is no evidence to suggest that a design or manufacturing issue caused or contributed to this event.The reported revision was likely the result of underlying patient factors, which led to instability of the joint.

• Brand Name: TRULIANT PS POR FEM PS POR LEFT 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 13260560
• Report Number: 1038671-2022-00027
• Device Sequence Number: 4760837
• Product Code: JWH
• UDI-Device Identifier: 10885862314772
• UDI-Public: 10885862314772
• 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: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2022

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 Model Number: TRULIANT PS POR FEM PS POR LEFT SZ 2.5
• Device Catalogue Number: 02-020-12-0225
• 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: 12/26/2021
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2020
• 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: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 76 KG