MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PSC TIBIAL 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	Pain (1994); Insufficient Information (4580)
Date of Event	02/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation the patient had a second revision on (b)(6) 2021.Approximately 7 months after the second revision the patient had a 3rd left knee revision on (b)(6) 2022.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.
Additional Manufacturer Narrative
Pending investigation.
Additional Manufacturer Narrative
D10.Concomitants: truliant femoral component (02-020-11-0245, 5233175) truliant fit tibial tray (02-022-45-4545, 6089823).H3.Investigation results-the cause of the patient¿s pain and subsequent surgical procedure 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 patella was not resurfaced during the arthroplasty.These devices are used for treatment not diagnosis.
Event or Problem Description
Additional information- operative report - postoperative diagnosis: chondromalacia left patella.History of left tka complicated by wound dehiscence and subsequent infection was treated with irrigation debridement and liner exchange.Continued to have persistent pain and discomfort despite no obvious occult infection or continued infection active within the knee.Painful tka, chondromalacia patella.Remaining fat pad was scarred and was debrided and the patella devoid of significant cartilage and showed signs of inflammation.Debrided soft tissue along with the patellar tendon and lateral gutter was sent to pathology and pathology determined there was no evidence of active infection with well less than 5 pmns per high-powered field noted.Tibial and femoral components well seated and no evidence of loosening or occult infection.Left patellofemoral arthroplasty.The patient was implanted with a competitors patella component.The patient was then brought to the recovery room in stable condition.There is no additional information available.

• Brand Name: TRULIANT PSC TIBIAL 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: 17398273
• Report Number: 1038671-2023-01783
• Device Sequence Number: 17625206
• 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: 2022
• 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 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: 09/28/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male