MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT TIB IMP PSC INSERT SZ 4, 9MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: truliant ps cem fem ps cem right sz 4 (cat# 02-020-11-0340 / (b)(4)); truliant tib fit tray cem sz 4f / 3t (cat# 02-022-45-4030 / (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately ten months post initial right tka, this (b)(6) male patient was experiencing knee pain.Surgeon decided to revise the femoral and tibial components.The patient was revised to exactech knee revision components.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep.Was unable to obtain photos or x-rays.The devices are not available for evaluation due to implants hazardous for being in patients' body.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3, h6 and h9 have been updated accordingly.(h3) as reported, approximately ten months post initial right tka, this 55 y/o male patient was experiencing knee pain.Surgeon decided to revise the femoral and tibial components.The patient was revised to exactech knee revision components.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep.Was unable to obtain photos or x-rays.The devices are not available for evaluation due to implants hazardous due to being in patients' body.No additional information.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision for 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 IMP PSC INSERT SZ 4, 9MM
• 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: 14161605
• Report Number: 1038671-2022-00439
• Device Sequence Number: 14901726
• Product Code: JWH
• UDI-Device Identifier: 10885862305268
• UDI-Public: 10885862305268
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 09/19/2022

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 IMP PSC INSERT SZ 4, 9MM
• Device Catalogue Number: 02-022-44-4009
• 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: 03/31/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0019 THRU 0027-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 128 KG