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

Model Number	208-25-09
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377); Joint Laxity (4526); Joint effusion (4849)
Date of Event	02/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10.Concomitants: (b)(6), 02-012-45-5040 - lgc tibial fit tray cem sz 5f / 4t; (b)(6), 200-02-38 - three peg patella 38mm; (b)(6), 204-34-04 - fluted stem extension 40l x 14 mm; (b)(6), 210-01-05 - nmc femoral sz 5.
Event or Problem Description
As reported via legal documentation, a patient had left knee replacement surgery on (b)(6) 2015.They underwent left knee revision surgery on (b)(6) 2023, approximately 7 years 2 months after their initial procedure.(b)(6) 2023 op report notes that the patient indicated for surgery due to progressive pain and swelling, and that the patient had moderate effusion without any clinical signs of infection.They were also noted to have had significant instability especially in flexion with lateral laxity.Intraoperative findings revealed all components to be well fixed.There was a large effusion with normal-appearing joint fluid.There were no signs of infection.There was expected synovial hypertrophy consistent with polyethylene liner wear.The constrained condylar polyethylene liner had severe medial sided wear with delamination, and there was also severe wear involving the intercondylar spine.The patellar component was also severely worn and felt to be appropriate for revision.There was cavitary osteolysis primarily in the lateral femoral condyle.There was minimal or no osteolysis on the tibial side.The tibia was revised due to relative valgus position that added to the instability.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.
Additional Manufacturer Narrative
The revision reported was likely the result of prosthesis wear, osteolysis, and instability.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the prosthesis wear, osteolysis, and instability could not be confirmed as the devices were not returned for evaluation, and images and radiographs were not available.

• Brand Name: CC TIBIAL INSERT SZ 5, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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: matt collins ; 3523782617
• MDR Report Key: 17299689
• Report Number: 1038671-2023-01607
• Device Sequence Number: 19761863
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2026

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: 03/28/2016
• Device Model Number: 208-25-09
• Device Catalogue Number: 208-25-09
• 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: 06/09/2023
• Supplement Date Received by Manufacturer: 03/29/2024; 09/24/2026
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 04/22/2024; 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2011
• 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: 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: 60 YR
• Patient Sex: Male