MAUDE Adverse Event Report: EXACTECH, INC. TRAPEZOID TIBIAL TRAY SZ 3F/2T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	204-04-32
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526); Implant Pain (4561); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2008, patient underwent a left total knee replacement surgery and was implanted with an exactech knee system.At the time of the implant, the exactech knee system implanted into patient was in substantially the same condition as when it left defendants' control.In the ensuing time, patient began to suffer from symptoms associated with the defects of the exactech knee system as alleged in this complaint, including pain and lack of mobility.As a result of these symptoms, patient underwent a revision of the left total knee on (b)(6) 2020.Patient experiences, pain, lack of mobility, and enduring limitations on activities of daily living, quality of life and ability to perform work functions.Mechanical loosening of internal left knee prosthetic joint; worsening instability.Clear synovial fluid sent for aspirate.Femoral component was removed without any bone loss.Utilized a rongeur to pull the tibial directly out.It was in considerable varus subsidence medially.Significant metaphyseal bone osteolysis in tibial component.Revision left tka.Patient was awake, alert, and oriented in stable condition when transferred from pacu to floor.
Additional Manufacturer Narrative
Report number: 1038671-2023-00560 multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-00560.Concomitants: (b)(6), 244-02-03 - optetrak asy hi-flex ps cem fem, sz 3, left.(b)(6), 200-02-32 - three peg patella 32mm.(b)(6), 244-23-09 - optetrak hi-flex tibial insert sz 3 9mm.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, and tibial loosening or due to inclusion of the polyethylene in the packaging recall.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.Potential contributions of 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: TRAPEZOID TIBIAL TRAY SZ 3F/2T
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 21082508
• Report Number: 1038671-2025-00091
• Device Sequence Number: 20939499
• Product Code: JWH
• UDI-Device Identifier: 10885862047656
• UDI-Public: 10885862047656
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/06/2025

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: 02/03/2013
• Device Catalogue Number: 204-04-32
• 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: 10/09/2023
• Initial Report FDA Received Date: 01/06/2025
• Date Device Manufactured: 02/05/2008
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female