MAUDE Adverse Event Report: EXACTECH INC. CC TIBIAL INSERT SZ 2, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	208-22-11
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Osteolysis (2377); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	06/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10.Pending investigation.There is no other information available.
Event or Problem Description
It was reported via legal documentation that a patient had a right total knee arthroplasty on (b)(6) 2009 and then experienced a revision surgical procedure on (b)(6) 2023 approximately 14 years after initial implant.No images of the devices are provided.The device will not be returned.There is no other information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b1 b2 g1 h6 the following sections were corrected: e1 h6 the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and femoral 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were corrected: b2- both hospitalization initial or prolonged and required intervention to prevent permanent impairment/damage (devices).The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and femoral 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were corrected: b1 both adverse event and product problem.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and femoral 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: CC TIBIAL INSERT SZ 2, 11MM
• 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: 18825532
• Report Number: 1038671-2024-00381
• Device Sequence Number: 12692926
• Product Code: JWH
• UDI-Device Identifier: 10885862054173
• UDI-Public: 10885862054173
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/27/2024

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: 03/22/2014
• Device Catalogue Number: 208-22-11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2023
• Supplement Date Received by Manufacturer: 11/22/2024; 11/22/2024; 11/22/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 11/27/2024; 11/27/2024; 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2009
• 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: UNK.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female