MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	205-25-11
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bacterial Infection (1735); Pain (1994); Scar Tissue (2060); Synovitis (2094); Osteolysis (2377); Joint Laxity (4526); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	04/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G4: 510k: per accessgudid.Nlm.Nih.Gov, device is exempt from premarket submission / pro code per accessgudid.Nlm.Nih.Gov is hwt.Investigation: 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.These devices are used for treatment not diagnosis.
Event or Problem Description
Per a report from the legal department the patient had a right knee replacement on (b)(6) 2005.Approximately 16 years and 7 months after the initial procedure the patient had a right knee revision on (b)(6) 2022.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.
Event or Problem Description
Revision operative report of (b)(6) 2022- the patient presented to the emergency room with a 3-day history of severe right knee pain and swelling.A right knee aspiration was performed revealing group b streptococcus infection and elevated cell count.Given these findings, the patient was diagnosed with a right knee periprosthetic joint infection.Preoperative diagnosis: right knee periprosthetic joint infection.Intraoperative findings: intraoperatively the knee was noted to have purulent appearing synovial fluid which was aspirated at the beginning of the case.The patient had extensive synovitis.There is scarring along the anterior aspect of the femur.On initial stability testing the medial collateral ligaments appeared lax.There is no osteomyelitic bone.The patellar button, tibial component, and femoral component were well fixed.Following removal of the tibia and femoral components as well as the patella button there was good bone stock.The medial and lateral femoral condyles were intact.The patient woke from anesthesia without complication/ transferred to post anesthesia care unit in stable condition.There is no other information available.
Additional Manufacturer Narrative
D10.Optetrak cemented trapezoid tibial tray (204-04-55; sn (b)(6)).Optetrak femoral and tibial fluted stem (204-32-01; sn (b)(6)).Optetrak 3 peg patella (200-02-38; sn (b)(6)).Optetrak nmc (210-01-05; sn (b)(6)).H3.Investigation results-the optetrak ncmc condylar tibial insert device with sn (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient¿s infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness "[chronic kidney disease and hypertension]" , unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.There is no other information available.

• Brand Name: CC TIBIAL INSERT SZ 5, 11MM
• 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: kate jacobson ; 3523771140
• MDR Report Key: 16859538
• Report Number: 1038671-2023-00887
• Device Sequence Number: 15347607
• Product Code: JWH
• 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: 2005
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/02/2009
• Device Model Number: 205-25-11
• Device Catalogue Number: 208-25-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 09/25/2023; 08/28/2026
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 09/25/2023; 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2004
• 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
• 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: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male