MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 2, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	208-22-13
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/03/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitant devices unknown.The device was not returned for evaluation and no photographs or x-rays were provided for review; therefore the reported event cannot be confirmed through analysis.No operative notes were provided; therefore, a review of device usage and technique could not be performed.No information concerning patient conditions, co-morbidities, or other health or anatomical concerns was provided and it is therefore unknown if patient-related factors may have caused or contributed to the reported event.The cause of the reported event cannot be determined based on the information made available.Should additional, relevant information become available, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported via email that approximately 108 months after a right total knee replacement procedure, the patient underwent a revision procedure.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
The reason for the revision reported cannot be determined from the available information but may have been reported at this later time due to inclusion of one of the implanted devices in the packaging recall.However, the alleged prosthesis wear could not be confirmed.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: CC TIBIAL INSERT SZ 2, 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 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19305715
• Report Number: 1038671-2024-01218
• Device Sequence Number: 12592936
• Product Code: JWH
• UDI-Device Identifier: 10885862054180
• UDI-Public: 10885862054180
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• 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,Followup
• Report Date (Section B): 02/24/2025

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: 10/24/2009
• Device Catalogue Number: 208-22-13
• 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: 04/25/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2004
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown