MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 5, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	CC TIBIAL INSERT SZ 5, 15MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	11/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation a 65 y/o male patient had a left knee replacement on (b)(6)2010.Approximately 10 years and 11 months after the initial procedure the patient had a left knee revision on (b)(6)2021.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.Revision op report on (b)(6)2021: it was noted that the tibial and femoral components were well fixed but easily separated from the bone cement interface.Postoperative diagnosis stated aseptic loosening with osteolysis and poly wear in the left knee.
Additional Manufacturer Narrative
D10: concomitants: 1878980 200-02-38 - three peg patella 38mm 1086342 204-04-55 - trapezoid tibial tray sz 5f/5t 1734008 204-34-04 - fluted stem extension 40l x 14 mm 1353615 210-01-05 - nmc femoral sz 5 pending investigation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6 (component code, type of investigation, investigation findings, investigation conclusions).The following sections were corrected: h6 (health effect - clinical code).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.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: CC TIBIAL INSERT SZ 5, 15MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• 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 ; 3523771140
• MDR Report Key: 17299947
• Report Number: 1038671-2023-01608
• Device Sequence Number: 11691314
• Product Code: JWH
• UDI-Device Identifier: 10885862054432
• UDI-Public: 10885862054432
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/27/2012
• Device Model Number: CC TIBIAL INSERT SZ 5, 15MM
• Device Catalogue Number: 208-25-15
• 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: 06/12/2023
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2007
• 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: 65 YR
• Patient Sex: Male