MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; OPTETRAK ASY HI-FLEX PS CEM FEM, SZ 2, RIGHT

Model Number	244-03-02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical device(s): trapezoid tibial tray sz 1f/2t, 2f/2t , (cn: 204-04-22, sn; (b)(4)).Optetrak hi-flex tibial insert, sz 2, 9mm (cn: 244-22-09, sn: (b)(4)).
Event or Problem Description
Revision of a right knee - reason not reported.This is a female patient initial implanted on the right side on (b)(6) 2009.Femoral and tibial components were removed and revised on (b)(6) 2019.Patella looks to have not been removed.
Event or Problem Description
As reported, approximately 10 years after initial implant, the 53 y/o female patient was revised.The patient was revised for aseptic loosening.Devices not returning as they were retained by the patient.No other information available at this time.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the reason for the revision reported was likely the result of an insufficient bond between the implant and the bone, which led to aseptic (non-infected) loosening.However, this cannot be confirmed as the devices were not available for evaluation.(d11) concomitant device(s): - trapezoid tibial tray sz 1f/2t, 2f/2t, (cn: 204-04-22, sn; (b)(6) optetrak hi-flex tibial insert, sz 2, 9mm (cn: 244-22-09, sn: (b)(6).

• Brand Name: OPTETRAK
• Common Device Name: OPTETRAK ASY HI-FLEX PS CEM FEM, SZ 2, RIGHT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9369082
• Report Number: 1038671-2019-00584
• Device Sequence Number: 16716077
• Product Code: JWH
• UDI-Device Identifier: 10885862063830
• UDI-Public: 10885862063830
• 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: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2020

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: 01/19/2014
• Device Model Number: 244-03-02
• Device Catalogue Number: 244-03-02
• Device Lot Number: 1408878
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR