MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 5 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT TIB IMP PS INSERT SZ 5 9MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Osteolysis (2377); Joint effusion (4849)
Date of Event	06/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately fifteen months post initial left tka, the 72 y/o male patient had a poly insert exchange.This is the third surgery with exactech.Patient had a primary knee done on (b)(6) 2019.Then a exactech femoral revision on (b)(6) 2021.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 device is not available for evaluation due to hospital will not release the implants.
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 fifteen months post initial left tka, the 72 y/o male patient had a poly insert exchange.This is the third surgery with exactech.Patient had a primary knee done on (b)(6) 2019.Then a exactech femoral revision on (b)(6) 2021.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 device is not available for evaluation due to hospital will not release the implants.Multiple attempts were made for additional information, no information available.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 the subsequent revision cannot be conclusively determined, reason not reported.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b5, h6 clinical codes.The investigation has been re-opened.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
Additional information received reported that the revision was performed secondary to persistent pain, large effusions, and discomfort.X-ray evidence showed continued osteolytic erosion beneath the tibial plateau.During the revision, the femoral component was checked and was well fixed.Infection workup was performed including fluid and tissue for gram stain and culture and was negative.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 5 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: 14838870
• Report Number: 1038671-2022-00727
• Device Sequence Number: 4743840
• Product Code: JWH
• UDI-Device Identifier: 10885862304612
• UDI-Public: 10885862304612
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/02/2025

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 PS INSERT SZ 5 9MM
• Device Catalogue Number: 02-022-35-5009
• 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: 06/08/2022
• Supplement Date Received by Manufacturer: 09/06/2022; 05/03/2024
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 09/28/2022; 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2020
• 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-0023-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male