MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB FIT TRAY CEM SZ 3F / 3T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT TIB FIT TRAY CEM SZ 3F / 3T
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	01/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the exactech knee replacement study, approximately three months post initial tka, the (b)(6) female patient complains that because of post -op infections and loss of range of motion.Patient documents that she is more crippled than before surgery.The even is still ongoing.Per clinical study case report this event is possibly related to devices and to procedure.
Additional Manufacturer Narrative
Concomitants medical product: femoral component (cat# 02-020-13-3011), tibial insert (cat# 02-022-47-3030), three peg patella 32mm (cat# 200-02-32), optetrak (4) holding pins (cat# 201-78-15).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H3: as reported by the exactech knee replacement study, approximately three months post initial right tka, the 53 y/o female obese patient complains that because of post -op infections and loss of range of motion.¿patient documents that she is more crippled than before surgery.¿ the event is still ongoing.Per clinical study case report this event is possibly related to devices and to procedure.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of infection cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.

• Brand Name: TRULIANT TIB FIT TRAY CEM SZ 3F / 3T
• 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: 14632598
• Report Number: 1038671-2022-00653
• Device Sequence Number: 3626225
• Product Code: JWH
• UDI-Device Identifier: 10885862305824
• UDI-Public: 10885862305824
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2022

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 TIB FIT TRAY CEM SZ 3F / 3T
• Device Catalogue Number: 02-022-45-3030
• 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: 05/19/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 53 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Race: White