MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 4, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	208-24-15
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Joint Laxity (4526); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	10/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal that on july 30, 2015, a male patient underwent a right total knee replacement surgery and was implanted with an optetrak device.On (b)(6) 2022, the patient had a revision surgery for unknown reasons.No additional information.
Additional Manufacturer Narrative
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.Correctional/removal number: z-0019-2022.
Additional Manufacturer Narrative
As a result of additional information and re-opened investigation, the following fields have been updated: a2, b5, d8, e4, and h6.H6: investigation results - the revision reported was likely due to prosthesis wear, instability, and failure of the cement used to secure the femoral component to the femoral bone, which led to loosening at the cement-implant interface.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, instability, and femoral debonding could not be determined as there were no details regarding cementing technique or environmental conditions provided, the devices were not returned for evaluation, and images and radiographs were not provided.Initial submission: all fields in section f should be blank, this is a manfucatrurer's report.
Event or Problem Description
As reported via legal documentation, a patient had right knee replacement on (b)(6) 2015.They underwent right knee revision on (b)(6) 2022, approximately 7 years 3 months post primary procedure.Revision op report postoperative diagnosis: instability; femoral component debonding.The surgeon noted there was delamination of the polyethylene but no evidence of gross prosthesis loosening.The tibia was well fixed but there was debonding of the femoral component at the implant cement interface.The patellar interface was intact and there was no significant 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Corrected fields: h6 clinical codes and component code additional information fields: b5, d10, g.D10: optetrak three peg cemented patella (200-02-38, (b)(6)).Optetrak tray tib cemtrap 4f/4t (204-04-44, (b)(6)).Stem ext flut 12mm x 11 mm (204-32-01, (b)(6)).Optetrak non-modular insert tib cc sz 4 (208-24-15, (b)(6)).Optetrak femur cck non-mod cem #4 (210-01-04, (b)(6)).Non exactech simplex hv bone cement x.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely due to prosthesis wear, instability, and failure of the cement used to secure the femoral component to the femoral bone, which led to loosening at the cement-implant interface.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, instability, and femoral debonding could not be determined as there were no details regarding cementing technique or environmental conditions provided, the devices were not returned 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 4, 15MM
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15811713
• Report Number: 1038671-2022-01482
• Device Sequence Number: 12199371
• Product Code: JWH
• UDI-Device Identifier: 10885862054357
• UDI-Public: 10885862054357
• 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: 2015
• 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,Followup
• Report Date (Section B): 04/25/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/21/2020
• Device Model Number: 208-24-15
• Device Catalogue Number: 208-24-15
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/27/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2022
• Supplement Date Received by Manufacturer: 11/06/2023; 08/16/2023; 04/24/2025
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 11/15/2023; 02/18/2025; 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2015
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male