MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT CR CEM FEM CR CEM LEFT SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT CR CEM FEM CR CEM LEFT SZ 4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant device: truliant tib fit tray cem sz 4f / 4t (cat# 02-022-45-4040 / serial# (b)(4) ) truliant tib imp crc insert sz 4, 10mm (cat# 02-022-51-4010 / serial# (b)(4) ) additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 2 yrs postop the initial ltka.The (b)(6) male patient had a revision due to much osteolysis especially on the femur.Surgeon associated the extensive osteolysis with the femur fracture.Revised left tibia and femur to truliant cc revision implants.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 d9, g3, g6, h2, h3 and h6 have been updated accordingly.(h3) as reported, approximately 2 yrs postop the initial ltka.The 54 y/o male patient had a revision due to much osteolysis especially on the femur.Surgeon associated the extensive osteolysis with the femur fracture.Revised left tibia and femur to truliant cc revision implants.Patient was last known to be in stable condition following the event.Upon review of the available information, there is no evidence that this is a device related problem and there is no allegation against the device.This cause of the reported event is most likely patient conditions, however; cannot be confirmed as the device was not returned for evaluation.

• Brand Name: TRULIANT CR CEM FEM CR CEM LEFT SZ 4
• 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: 12338662
• Report Number: 1038671-2021-00394
• Device Sequence Number: 4542029
• Product Code: JWH
• UDI-Device Identifier: 10885862320643
• UDI-Public: 10885862320643
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K170240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 01/24/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TRULIANT CR CEM FEM CR CEM LEFT SZ 4
• Device Catalogue Number: 02-020-13-0240
• 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: 07/29/2021
• Supplement Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 01/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2018
• 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: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male