MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 3.5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-44-3511
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Scar Tissue (2060); Implant Pain (4561)
Date of Event	12/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal notification: a male patient had an initial right knee arthroplasty on (b)(6) 2020, and then underwent revision surgery on (b)(6) 2022, approximately 2 years after implant procedure.Revision surgery operative report of (b)(6) 2022-failed right knee arthroplasty secondary to aseptic loosening and poly wear.Obese bmi 37-the duration of the procedure was increased by approximately 40%, due to patient size, this increased complexity and difficulty of surgical procedure.Findings: intraoperative findings confirmed the radiographic and clinical findings of failure of the knee arthroplasty secondary to aseptic loosening (femoral component, tibial component well fixed) characterized by no bony ingrowth on the backside of the femoral component with easy component removal.Abundant polyethylene particles throughout the knee.Poly was removed and inspected, there was notable wear on the tibial post.The patella was found to be well-fixed and without significant surface damage, delamination or pitting; it was decided to place a new button.A dressing and wrap were applied, the patient was transferred to the recovery room.The patient tolerated the procedure well without complications.Patient discharged (b)(6)2023.¿previous components were kept and to be sterilized and sent to my office per patient request.¿ 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.
Additional Manufacturer Narrative
Device information was not provided.Pending investigation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported was likely the result of prosthesis wear and femoral loosening and/or due to inclusion of the polyethylene in the packaging recall.Potential contributions of manufacturing, user, and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.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 PSC INSERT SZ 3.5, 11MM
• 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 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16824514
• Report Number: 1038671-2023-00852
• Device Sequence Number: 6735789
• Product Code: JWH
• UDI-Device Identifier: 10885862305190
• UDI-Public: 10885862305190
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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: 09/15/2025
• Device Catalogue Number: 02-022-44-3511
• 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: 04/06/2023
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2017
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male