MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM LEFT SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	TRULIANT PS CEM FEM PS CEM LEFT SZ 5
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/28/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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 PS CEM FEM PS CEM LEFT SZ 5
• 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 ; 3523771140
• MDR Report Key: 16196124
• Report Number: 1038671-2023-00015
• Device Sequence Number: 5971058
• Product Code: JWH
• UDI-Device Identifier: 10885862314475
• UDI-Public: 10885862314475
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K170240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2026

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 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2022
• Supplement Date Received by Manufacturer: 10/11/2023; 05/06/2026
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 11/01/2023; 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2019
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 177 LB
• Patient Race: White