MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 3, 18MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Catalog Number	208-23-18
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Joint Laxity (4526); Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device return anticipated due to facility policy.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported via a legal notification that male patient, initially implanted with optetrak knee replacement system in 2011, exact date unknown, following seeing news that his knee replacement was recalled, obtained mri¿s and x-rays of his knee which confirmed that the recalled polyethylene insert had degraded to such extent that it was causing extensive bone damage.He underwent revision surgery on (b)(6) 2022 approximately 11 years 6 months post the initial procedure.The knee replacement system was removed, and bone reconstruction was performed.No devices will be returning as the customer retains all devices.
Additional Manufacturer Narrative
As a result of the investigation, the following fields have been updated: d1, d4, g4, h4, h6, h7, and h9.H6: investigation results - the revision reported may have been the result of femoral loosening and prosthesis wear.The aseptic (non-infected) loosening was likely the result of an insufficient bond between the component(s) and the bone.A contributing factor to the loosening may have been deterioration of the bond after being implanted for over 10 years.The tibial insert wear may have been due to malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.However, this cannot be confirmed as the devices were not available for evaluation and radiographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.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 reason for the revision reported cannot be confirmed from the information provided but may be the result of instability, prosthesis wear and 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 3, 18MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15374494
• Report Number: 1038671-2022-01052
• Device Sequence Number: 5820998
• Product Code: JWH
• UDI-Device Identifier: 10885862054289
• UDI-Public: 10885862054289
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/19/2025

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: 09/09/2012
• Device Catalogue Number: 208-23-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: 09/18/2023; 02/19/2025; 05/16/2025
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 09/22/2023; 02/19/2025; 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2007
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0019-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male