MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 4, 12MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT TIB IMP PSC INSERT SZ 4, 12MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: truliant ps cem fem ps cem left sz 4 (cat# 02-020-11-0240).Truliant tib fit tray cem sz 4f / 4t (cat# 02-022-45-4040).Three peg patella 35mm (cat# 200-02-35).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, patient said that since his surgery his knee has been swollen and he has been in pain.He said that his surgeon said he will need a revision because he is ¿highly allergic to nickel¿.No additional information available.
Additional Manufacturer Narrative
As reported, patient said that since his surgery his knee has been swollen and he has been in pain.He said that his surgeon said he will need a revision because he is ¿highly allergic to nickel¿.No additional information available.Upon review of the available information, it is likely the results of the patient¿s nickel allergy, which can cause inflammation around the knee joint.¿metal sensitivity reactions or other allergic/histological reactions to implant materials¿ is stated in the product labeling under device specific risks.The most likely cause of the reported event is patient¿s conditions.

• Brand Name: TRULIANT TIB IMP PSC INSERT SZ 4, 12MM
• 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: 14024950
• Report Number: 1038671-2022-00379
• Device Sequence Number: 14939372
• Product Code: JWH
• UDI-Device Identifier: 10885862305299
• UDI-Public: 10885862305299
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2022

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 Expiration Date: 11/27/2025
• Device Model Number: TRULIANT TIB IMP PSC INSERT SZ 4, 12MM
• Device Catalogue Number: 02-022-44-4012
• 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: 03/17/2022
• Supplement Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2017
• 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 Sex: Male