MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM LEFT SZ 4.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT PS CEM FEM PS CEM LEFT SZ 4.5
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately three years post initial left tka, this (b)(6) male patient complained of pain.Loose femur.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Photos received.The device is not available for evaluation due to chain of custody for hospital and patient.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Upon further investigation, information was reviewed, and it was noted that this case is a duplicate of mfr# 1038671-2022-00015; therefore, this case will be voided.Any subsequent information will be captured under mfr# 1038671-2022-00015.

• Brand Name: TRULIANT PS CEM FEM PS CEM LEFT SZ 4.5
• 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: 13921308
• Report Number: 1038671-2022-00279
• Device Sequence Number: 20393962
• Product Code: JWH
• UDI-Device Identifier: 10885862314468
• UDI-Public: 10885862314468
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2022

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 PS CEM FEM PS CEM LEFT SZ 4.5
• Device Catalogue Number: 02-020-11-0245
• 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: 03/02/2022
• Supplement Date Received by Manufacturer: 04/11/2022; 08/22/2022
• Initial Report FDA Received Date: 03/26/2022
• Supplement Report FDA Received Date: 04/11/2022; 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: - ADVANCED PATELLA 35MM 3 PEG IMPLANT; - TRULIANT TIB IMP PS INSERT SZ 4.5 12MM; TRULIANT TIB FIT TRAY CEM SZ 4.5F/3.5T
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male