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

Catalog Number	204-04-33
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060)
Date of Event	11/04/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 11 months after a right total knee replacement procedure, the patient has experienced prosthesis wear, pain and scar tissue.No further issues or complications were reported.Patient underwent revision right knee (b)(6) 2014.Pre/post op: painful right tka procedure: revision right tka ¿ tibial component only findings: no infection arthrofibrosis tissue about the patella.Indications for surgery: patient is a 49-year-old female who has had both knees replaced.She did well with the left knee replacement, however, she has had some continued pain with the right knee replacement.She underwent an extensive workup.Infection work-up was negative.The tibial component based on a dt scan was read as very mildly internally rotated at 21 degrees.Givin the amount of pain she was having and the fact that the patella was somewhat subluxed laterally.It was decided to proceed with a revision.I was confident the femoral component was well fixed and positioned however, we were prepared to revise that, if necessary, the plan was for a tibial revision and to address the patella.Operative notes: the tibial component was easily removed with minimal bone loss.She had a hard arthrofibrosis tissue surrounding the whole patella.It was excised without any damage to the patella button itself.Patient was brought to the recovery room in stable condition.No additional information is available.
Additional Manufacturer Narrative
Report number: 1038671-2024-02434 multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-02434.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear or due to inclusion of the polyethylene in the packaging recall.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/3T
• 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: 21093027
• Report Number: 1038671-2025-00119
• Device Sequence Number: 15739646
• Product Code: JWH
• UDI-Device Identifier: 10885862047663
• UDI-Public: 10885862047663
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2014
• 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): 01/07/2025

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: 03/25/2015
• Device Catalogue Number: 204-04-33
• 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: 07/12/2024
• Initial Report FDA Received Date: 01/07/2025
• Date Device Manufactured: 03/29/2010
• 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: Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female