MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	208-25-09
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Aseptic loosening (4883)
Date of Event	03/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial bilateral tka on (b)(6) 1995.The patient had a previous right knee revision on (b)(6) 2010 due to unknown reasons.The patient's right knee was revised again on (b)(6) 2021 due to unknown reasons.No further patient information/medical history provided.
Additional Manufacturer Narrative
Pending investigation.
Additional Manufacturer Narrative
H3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined, insufficient information h7: z-0019-2022.
Additional Manufacturer Narrative
Additional information - a2, b6, b7, d8, d10 h6.Investigation results - the revision reported was likely the result of a degradation of the bond between the tibial tray and the bone and patient-related conditions after being implanted for over 10 years, which led to aseptic (non-infected) tibial loosening.However, this cannot be confirmed as the devices were not returned for evaluation and images of the explanted devices and pre-revision radiographs were not provided.These devices are used for treatment not diagnosis.There is no other information available.Correction, f6, f8-blank.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3/g4, h6.The following sections were corrected: h6.Mdr section codes updated/corrected: b, e, g.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and tibial 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.
Event or Problem Description
Report #1 of 2 for this event.It was reported a patient underwent a right total knee revision approximately fourteen (14) years, four (4) months after an initial bilateral total knee arthroplasty procedure.Subsequently, nine (9) years, seven (7) months later, the patient underwent a second right knee revision procedure due to aseptic (non-infected) loosening of the tibial component.An operative report was provided.The femoral component was noted to be well fixed.It was noted there was no peri-operative complications.The patient was noted to be in stable condition.No further patient impact was reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following corrections have been made: b1, b2, b5, g2 (correcting initial report), g3 (correct follow up report #3 to 21-jan-2026), h6: clinical code, h10.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2025-00167 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, 9MM
• 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: 15759457
• Report Number: 1038671-2022-01431
• Device Sequence Number: 14996113
• Product Code: JWH
• UDI-Device Identifier: 10885862054401
• UDI-Public: 10885862054401
• 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: 2010
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/11/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/10/2013
• Device Model Number: 208-25-09
• Device Catalogue Number: 208-25-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/12/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2022
• Supplement Date Received by Manufacturer: 11/14/2022; 07/25/2023; Not provided; 02/11/2026
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 12/01/2022; 08/08/2023; 01/10/2025; 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2009
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male