MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM LEFT SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-020-11-0250
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 4 years post op the initial left tka, this 63 y/o male patient was revised due to and a loose femur.Patient was complaining of pain.Patient was last known to be in stable condition following the event.Devices are not returning, hospital will not release.
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 5057695 02-022-35-5012 - truliant tib imp ps insert sz 5 12mm, 5428300 02-022-45-5050 - truliant tib fit tray cem sz 5f / 5t, 5243033 200-02-41 - three peg patella 41mm, 5261857 201-78-18 - holding pin headless no ribs w/30 deg pt 4 pack.
Additional Manufacturer Narrative
Section h10: (h3) this event has been determined to be a duplicate.Please reference 1038671-2022-01134 for additional information.

• Brand Name: TRULIANT PS CEM FEM PS CEM LEFT SZ 5
• Common Device Name: 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: 15761173
• Report Number: 1038671-2022-01434
• Device Sequence Number: 15502206
• Product Code: JWH
• UDI-Device Identifier: 10885862314475
• UDI-Public: 10885862314475
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K170240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2023

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
• Operator of Device: Health Professional
• Device Model Number: 02-020-11-0250
• Device Catalogue Number: 02-020-11-0250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2022
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2017
• 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: 63 YR
• Patient Sex: Male