MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number TRULIANT PS CEM FEM PS CEM LEFT SZ 5

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/28/2022

Event Type  Injury  

Event Description

It was reported via an exactech truliant knee clinical study, that a 64 yo male patient, initial left tka on (b)(6) 2019, underwent a revision procedure on (b)(6) 2022, approximately 2 years 7 months post the initial procedure.Date of onset, (b)(6) 2022.Femoral loosening and recalled poly resulted in the revision of the femoral and tibial components.Outcome indicates resolved on the date of the procedure.No devices returning due to clinical study guidelines.No further information.

Manufacturer Narrative

Concomitant medical products: product id: 02-022-35-5010 - truliant tib imp ps insert sz 5 10mm, (b)(4), serial number (b)(4) is confirmed to have been packaged in a vacuum bag that does not contain evoh.02-022-45-5040 - truliant tib fit tray cem sz 5f / 4t, (b)(4), 200-07-35 - advanced patella 35mm 3 peg implant, (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Manufacturer Narrative

H3: the femoral loosening reported is most likely the result of either a weakened biologic integration of the femoral component at the bone-implant interface or mechanical loss of fixation at the cement-implant interface.However, the failure cannot be confirmed as the device was not returned for investigation, pre-revision x-rays were unable to be obtained, and potential contributions from the type of cement used, cementing technique, or environmental conditions in the operating room at the time of implantation cannot be determined from the provided information.Inclusion of the implanted polyethylene tibial insert in the packaging recall may have been a contributing factor to the reported revision.

• Brand Name: TRULIANT
• Type of Device: 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 ; 3523771140
• MDR Report Key: 16196124
• MDR Text Key: 307604728
• Report Number: 1038671-2023-00015
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862314475
• UDI-Public: 10885862314475
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TRULIANT PS CEM FEM PS CEM LEFT SZ 5
• Device Catalogue Number: 02-020-11-0250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0023-2022
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White