MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	SPECIFIC DEVICE NOT REPORTED
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Insufficient Information (4580)
Date of Event	07/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a left knee revision on (b)(6) 2021.Approximately 1 month after the 1st revision the patient had a 2nd revision on (b)(6) 2021.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Event or Problem Description
Additional information-post operative diagnosis: left knee septic arthritis.Left knee poly exchange/ antibiotic beads.Significant tissue loss at the most inferior aspect of the capsule was noted and the prior sutures were cut and excised.Thorough debridement of extra capsular tissue was well as a thorough synovectomy and debridement of the intracapsular tissue was performed using electrocautery as well as a rongeur.The polyethylene liner was removed at this time and debridement of the posterior capsules was performed.The patient was then brought to the recovery room in stable condition.There is no additional information.
Additional Manufacturer Narrative
D10.Concomitants: 5233175 02-020-11-0245 - truliant ps cem fem ps cem left sz 4.5, 6089823 02-022-45-4545 - truliant tib fit tray cem sz 4.5f/4.5t, 3009021250 a10012 - gps implant kit v2.H3.Investigation results-the cause of the patient¿s left knee septic arthritis and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.The patient had a surgery for wound dehiscence one month previous to this event.Per the ifu: the patient should be cautioned to monitor activities and protect the replaced joint from unreasonable stresses and follow the written instructions of the physician with respect to follow-up care and treatment.Patients should be informed that their weight and activity level may affect the longevity of the implant.Device was released appropriately.These devices are used for treatment not diagnosis.There is no additional information available.

• Brand Name: TRULIANT TIB IMP PSC INSERT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 17397670
• Report Number: 1038671-2023-01779
• Device Sequence Number: 5955342
• Product Code: JWH
• UDI-Device Identifier: 10885862305350
• UDI-Public: 10885862305350
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2024

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: 04/11/2026
• Device Model Number: SPECIFIC DEVICE NOT REPORTED
• Device Catalogue Number: 02-022-44-4509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male