MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 3, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	CC TIBIAL INSERT SZ 3, 13MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544)
Date of Event	12/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation a female patient had a right knee replacement on (b)(6) 2011.Approximately 11 years and 7 months after the initial procedure the patient had a right knee revision due to prosthesis wear.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.Op report (b)(6) 2023/ k mcguinness received via legal (b)(6) 2023.Postoperative diagnosis: failed right knee due to polyethylene wear.Findings: partial loose femoral and tibial components with mild to moderate amount of osteolysis behind the femoral component and around the tibial component.The patellar component was well fixed but also had a moderate amount of polyethylene wear.An ace wrap from toe to thigh was applied.The patient was awakened and transferred to recovery in stable conditions with no complications.
Additional Manufacturer Narrative
D10: concomitants: 2031088, 200-02-35 - three peg patella 35mm.1692843, 204-04-34 - trapezoid tibial tray sz 3f/4t.2042025, 204-34-04 - fluted stem extension 40l x 14 mm.8504716, 210-01-03 - nmc femoral sz 3.Pending investigation.
Additional Manufacturer Narrative
Recall number: z-0019-2022.1038671-2025-00060, 1038671-2025-00059, 1038671-2025-00057 this follow-up report is being submitted to relay additional and/or corrected information.The product associated with the reported event is within the scope of recall z-0019-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2025-00060, 1038671-2025-00059, and 1038671-2025-00057.D10: concomitants: 2031088 200-02-35 - three peg patella 35 mm; 1692843 204-04-34 - trapezoid tibial tray sz 3f/4t; 2042025 204-34-04 - fluted stem extension 40l x 14 mm; 8504716 210-01-03 - nmc femoral sz 3.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, tibial loosening, 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 3, 13MM
• 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 ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16876222
• Report Number: 1038671-2023-00911
• Device Sequence Number: 7460437
• Product Code: JWH
• UDI-Device Identifier: 10885862054265
• UDI-Public: 10885862054265
• 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: 2011
• Device Explanted Year: 2022
• 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
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/23/2013
• Device Model Number: CC TIBIAL INSERT SZ 3, 13MM
• Device Catalogue Number: 208-23-13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10; SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female