MAUDE Adverse Event Report: EXACTECH, INC. TRU CC TIB INSERT SIZE 4, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-65-4013
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Ambulation or Postural Difficulties (2544); Implant Pain (4561); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: ((b)(6)) 200-02-35 - three peg patella 35mm.((b)(6)) 02-012-50-4011 - tru tib aug 1/2 size 4, 5mm.((b)(6)) 02-012-50-4011 - tru tib aug 1/2 size 4, 5mm.((b)(6)) 02-010-06-0340 - tru cc femoral size 4 right.((b)(6)) 02-012-60-1480 - tru stem ext 14mm x 80mm.((b)(6)) 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t.((b)(6)) 02-012-66-1000 - metaphyseal tibial cone, ml29mm.((b)(6)) 02-012-60-1680 - tru stem ext 16mm x 80mm.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
Legal case ¿ usa (mdl no.3044).It was reported via legal documentation that approximately 73 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear.Plaintiff michael canterbury is currently suffering from the following complications, injuries and/or indications, some or all of which made revision medical necessary: pain, discomfort, difficulty walking as a result of the defective nature of the exactech knee replacement system.Plaintiff has suffered and may continue to suffer, severe and permanent personal injuries, including polyethylene wear and device failure, disbursement of the polyethylene liner into bone and other bodily structures, painful knee revision surgeries to remove or revise the defective device, continued rehabilitation, medical care and possibly additional surgeries.Post operative diagnosis noted wear of the implant.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.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, radiographs, and relevant clinical information 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: TRU CC TIB INSERT SIZE 4, 13MM
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 20353410
• Report Number: 1038671-2024-03790
• Device Sequence Number: 6480024
• Product Code: JWH
• UDI-Device Identifier: 10885862266125
• UDI-Public: 10885862266125
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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: 02/23/2025
• Device Catalogue Number: 02-012-65-4013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2017
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown