MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 4.5 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-4509
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation the patient had a right knee replacement on (b)(6)2020.Approximately 2 years and 9 months after the initial procedure the patient had a right knee revision on (b)(6) 2023.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report on 27 mar 2023.Diagnosis: failed right total knee arthroplasty secondary to early polyethylene wear."he had synovitis with evidence of polyethylene debris in the gutters.I debrided some of the synovial tissue and sent this for culture.I cleared off the scar tissue from around the patellar button.I therefore decided to exchange it.I used a thin saw blade to remove the patellar button with no extra bone loss.I used a 2.5 mm drill bit and a small curette to remove the polyethylene pegs.The knee was flexed up.The previous tibial insert was removed using a 1/2-inch osteotome.On gross inspection, there was no obvious signs of wear.I started with removal of the femoral component.I used an offset osteotome and a 1/4-inch curved osteotome to work around the edges of the implant.I was able to disimpact the femoral component, which became delaminated from the cement mantle.The remaining cement from the distal femur was removed using a 1/4-inch osteotome and a rongeur.I opened the femoral canal and sent a sample of the bone and soft tissue for culture.I then exposed the tibia.I used an offset osteotome, a 1/4-inch curved and a 1/2-inch curved osteotome in order to break up the cement mantle.I was then able to disimpact the tibial component with minimal bone loss.I used a curved osteotome and a pituitary rongeur to remove the remaining cement from the proximal tibia." the patient was transferred to the recovery room in stable condition.
Additional Manufacturer Narrative
D10: concomitants: 4880918 02-020-11-0345 - truliant ps cem fem ps cem right sz 4.5.6434959 02-022-45-4545 - truliant tib fit tray cem sz 4.5f/4.5t.6516665 200-07-32 - advanced patella 32mm 3 peg implant.Pending investigation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information: please disregard this report as it was submitted in error.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 4.5 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: kate jacobson
• MDR Report Key: 18192572
• Report Number: 1038671-2023-02840
• Device Sequence Number: 20649149
• Product Code: JWH
• UDI-Device Identifier: 10885862304520
• UDI-Public: 10885862304520
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

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
• Device Catalogue Number: 02-022-35-4509
• 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: 09/05/2023
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2019
• 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-0023-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Unknown