MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK HI-FLEX TIBIAL INSERT, SZ 2, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	OPTETRAK HI-FLEX TIBIAL INSERT, SZ 2, 11MM
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: aa3614 13a2101 - cemex system fast genta 70g.1523454 200-02-29 - three peg patella 29mm.1740798 200-04-22 - cemented finned tib.Tra sz 2f/2t.1693834 201-46-10 - holding pin headless 3" (4 pk).98179 203-96-01 - (11-2222) saw blade new stryk (.050).1739984 244-03-02 - optetrak asy hi-flex ps cem fem, sz 2, right.
Event or Problem Description
Legal case - usa.This patient had original right knee implant (b)(6) 2010.The patient recently had right knee revision on (b)(6) 2022, approximately 12 years, 4 months after initial implant.Ebi initial surgery - attached.(b)(4) 244-22-11 - optetrak hi-flex tibial insert, sz 2, 11mm.Serial number 1473735 is confirmed to have been packaged in a vacuum bag that does not contain evoh.Pma/510k: k033883.Concomitant medical products: aa3614 13a2101 - cemex system fast genta 70g.1523454 200-02-29 - three peg patella 29mm.1740798 200-04-22 - cemented finned tib.Tra sz 2f/2t.1693834 201-46-10 - holding pin headless 3" (4 pk).98179 203-96-01 - (11-2222) saw blade new stryk (.050).1739984 244-03-02 - optetrak asy hi-flex ps cem fem, sz 2, right.
Additional Manufacturer Narrative
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.H3.Investigation results- the optetrak hi-flex tibial insert, sz 2, 11mm device with serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient's condition and revision surgery as related to the devices cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.There is no other information available.Corrected information- f10, should be blank.
Event or Problem Description
It was reported that the patient underwent an initial right total knee arthroplasty.Subsequently, it was reported that the patient experienced an unknown issue.As a result, the patient underwent a right knee revision approximately 12 years and 5 months after initial implantation.No further patient impact reported.No further information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b5, g1, h6 - component code, type of investigation, h7 and h11.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Medical records were provided for review.The review identified no abnormalities in usage or surgical technique performed.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was 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: OPTETRAK HI-FLEX TIBIAL INSERT, SZ 2, 11MM
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: katy priest ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523782617
• MDR Report Key: 16728288
• Report Number: 1038671-2023-00664
• Device Sequence Number: 6597299
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2026

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: 05/08/2017
• Device Model Number: OPTETRAK HI-FLEX TIBIAL INSERT, SZ 2, 11MM
• Device Catalogue Number: 244-22-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 10/03/2023; 04/24/2026
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 10/03/2023; 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2009
• 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; SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Race: White