MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT; TRULIANT TIB IMP PSC INSERT SZ 4, 17MM

Model Number	02-022-44-4017
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, approximately 14 months postop the initial left tka, this male patient had knee instability and required a revision.The surgeon used a 8mm logic pts spacer with a 15mm psc insert, which was a thicker poly.Patient was last known to be in stable condition following the event.Device will not return as the poly was sent off with tissue.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation of the of the revision reported based upon review of all available information, there is no evidence to suggest that a design or manufacturing issue caused or contributed to this event.The reported revision was likely the result of underlying patient factors, which led to instability of the joint over the course of 14 months.

• Brand Name: TRULIANT
• Common Device Name: TRULIANT TIB IMP PSC INSERT SZ 4, 17MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10786729
• Report Number: 1038671-2020-00600
• Device Sequence Number: 3025623
• Product Code: JWH
• UDI-Device Identifier: 10885862305336
• UDI-Public: 10885862305336
• Combination Product (Y/N): N
• Initial Reporter State: AS
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2021

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: 07/02/2026
• Device Model Number: 02-022-44-4017
• Device Catalogue Number: 02-022-44-4017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 01/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention