MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	208-25-11
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Emotional Changes (1831); Failure of Implant (1924); Scar Tissue (2060); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Implant Pain (4561); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.H7: z-0019-2022.
Event or Problem Description
As reported by legal notification, the patient had an initial right tka on (b)(6) 2012.The patient was revised on (b)(6) 2013; reason not reported.No other patient information/medical history reported.
Additional Manufacturer Narrative
Additional information: pending investigation correction: f6, f8, & f10 -should be blank.
Event or Problem Description
Additional information: the patient underwent right total knee revision surgery due to accelerated and preventable wear of the optetrak polyethylene tibial insert and aseptic loosening of the femoral component.Revision surgery was approximately 4 months, 19 days, post initial implant.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
H3.Investigation results - the cc tibial insert device with serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient's condition and revision surgery as related to the devices cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.There is no other information.Correction -b5.The patient was implanted (b)(6) 2012 and was revised on (b)(6) 2013; reason not reported.Revision of (b)(6) 2022 for prosthesis wear is reported in mfr#1038671-2023-00689.
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, femoral loosening, and fracture 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 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 corrected/ additional information.The following sections were corrected/added: b3, d4, d6a / d6b, h4, h6: clinical code.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, femoral loosening, and fracture.An additional contributing factor to the revision may have been inclusion of the polyethylene components 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 and radiographs were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following section was corrected: d4 (expiration date).Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: CC TIBIAL INSERT SZ 5, 11MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16740217
• Report Number: 1038671-2023-00688
• Device Sequence Number: 12437381
• Product Code: JWH
• UDI-Device Identifier: 10885862054418
• UDI-Public: 10885862054418
• 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: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/15/2026

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: 03/28/2015
• Device Model Number: 208-25-11
• Device Catalogue Number: 208-25-11
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/24/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 04/11/2023; 08/29/2023; 04/07/2025; 01/14/2026; 01/14/2026
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 05/11/2023; 08/29/2023; 04/08/2025; 01/15/2026; 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2010
• 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 Age: 75 YR
• Patient Sex: Male