MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; SEE H10

Model Number	CC TIBIAL INSERT SZ 5, 18MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 74 yo male patient, initial right knee implanted on (b)(6) 2002, underwent a revision procedure on (b)(6) 2024, approximately 21 years 5 months post the initial procedure.The poly wore over time.The patient was revised to a 208-25-22 cc tibial insert sz 5 22mm.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.No explanted devices are available for analysis.The hospital kept the devices.No device images or x-rays were able to be obtained.No further information.
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer d10: concomitants: 371534 - 204-04-55 - trapezoid tibial tray sz 5f/5t 386000 - 204-38-08 - stem extension 80l x18 mm 390631 - 204-40-08 - stem extension 80l x20 mm 177772 - 208-01-05 - cc femoral sz 5 193759 - 208-05-05 - cc distal fem augment sz 5, 5mm 193760 - 208-05-05 - cc distal fem augment sz 5, 5mm 189658 - 208-07-05 - cc posterior fem augment sz 5, 5mm additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
The revision reported was likely the result of prosthesis wear over 21 years of use.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, radiographs, and relevant clinical information were not provided.H6: corrected health effect and investigation clinical codes.

• Brand Name: OPTETRAK
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523782617
• MDR Report Key: 18881873
• Report Number: 1038671-2024-00459
• Device Sequence Number: 9049405
• Product Code: JWH
• UDI-Device Identifier: 10885862054449
• UDI-Public: 10885862054449
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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: 05/22/2005
• Device Model Number: CC TIBIAL INSERT SZ 5, 18MM
• Device Catalogue Number: 208-25-18
• 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: 02/14/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 12/03/2024
• Date Device Manufactured: 06/02/2000
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male