MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 4 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-4010
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Synovitis (2094); Osteolysis (2377); Swelling/ Edema (4577)
Date of Event	07/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation (d10) concomitant device(s): concomitants: 5382973 02-022-45-4030 - truliant tib fit tray cem sz 4f / 3t 5486778 200-07-29 - advanced patella 29m 3 peg implant 5025458 02-022-35-4010 - truliant tib imp ps insert sz 4 10mm.
Event or Problem Description
As reported, approximately 5 years post op initial right tka, this 73 y/o female patient was revised due to a loose femur and recalled poly.Patient had complained of pain.Due to recall surgeon is using competitor for revision.Patient was last known to be in stable condition following the event.No other patient information/medical history reported.X-ray & photo attached.Product not returning.Due to recall hospital will not release.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported may have been the result of aseptic (non-infected) femoral loosening possibly due to patient-related conditions and an insufficient bond between the femoral component and the bone, which likely contributed to the patient¿s pain.However, this cannot be confirmed as the device(s) were not returned for evaluation and operative notes were not provided.The tibial insert was revised but the image provided did not show signs of wear or other damage.
Additional Manufacturer Narrative
Corrected b2, b3, d4, d10, g2, g4, h6: clinical codes, medical device problem code and component code.Updated b5.
Event or Problem Description
It was reported that approximately 60 months after a right knee total replacement procedure, the patient has experienced prosthesis wear, chronic pain and swelling.Post operative report was provided.Intraoperatively, the surgeon observed polyethylene synovitis, scar tissue and wear of the patella button, wear of the polyethylene insert, lysis around the lateral condyle.No further issues or complications were reported.No other patient information/medical history reported.
Additional Manufacturer Narrative
Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-04741.This follow-up report is being submitted to relay additional and/or corrected information.The revision reported may have been the result of aseptic (non-infected) femoral loosening possibly due to patient-related conditions and an insufficient bond between the femoral component and the bone, which likely contributed to the patient¿s pain.However, this cannot be confirmed as the device(s) were not returned for evaluation and operative notes were not provided.The tibial insert was revised but the image provided did not show signs of wear or other damage.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.".

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 4 10MM
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17555803
• Report Number: 1038671-2023-01964
• Device Sequence Number: 20095074
• Product Code: JWH
• UDI-Device Identifier: 10885862304445
• UDI-Public: 10885862304445
• 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: 2018
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/19/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/15/2025
• Device Catalogue Number: 02-022-35-4010
• 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: 07/26/2023
• Supplement Date Received by Manufacturer: 07/26/2023; 07/26/2023; 02/18/2025
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 11/28/2023; 12/10/2024; 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2017
• 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.; SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female