MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 3, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	208-23-11
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	03/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D11: optetrak tibial insert & screw constrained condylar (208-23-11, (b)(6) optetrak 3 peg patella (200-02-35, (b)(6) optetrak fluted stem extension femoral and tibial (204-32-01, (b)(6) optetrak tibial tray (204-04-32, (b)(6) optetrak femoral component non-modular constrained (210-01-03, (b)(6).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.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, failure of the cement used to secure the femoral component to the femoral bone, which led to loosening at the cement-implant interface, tibial loosening, and infection 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.
Event or Problem Description
As reported via legal documentation, a patient had right knee replacement surgery due to osteoarthritis.They underwent right knee revision surgery approximately 8 years 8 months post primary procedure.Operative report operative findings: gross purulence and infection, loose femoral component, loose tibial component, well-fixed patellar component, adequate soft tissue coverage, aori class femur 2b, aori class tibia 2b.Postoperative diagnosis: pyogneic arthritis of right knee joint, due to unspecified organism.The surgeon noted abundant purulence.The femoral component was noted to be loose and completely debonded from the bone, where abundant purulence was noted in the femur around the implant, which was removed.The polyethylene was removed and the tibial component was also noted to be loose with severe bone loss and purulence in the bone.The patellar bone had osteolysis as well over the lateral facet.She tolerated the procedure well without complication.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.

• Brand Name: CC TIBIAL INSERT SZ 3, 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 22815164
• Report Number: 1038671-2025-02765
• Device Sequence Number: 17577341
• Product Code: JWH
• UDI-Device Identifier: 10885862054258
• UDI-Public: 10885862054258
• 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: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/15/2025

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: 07/18/2016
• Device Catalogue Number: 208-23-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2023
• Initial Report FDA Received Date: 08/15/2025
• Date Device Manufactured: 07/21/2011
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female