MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; CR TIBIAL INSERT SZ 2, 9MM, SLOPE +

Model Number	200-62-09
Health Effect - Clinical Codes	Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant devices: (cn: 200-02-32, sn: (b)(4)) three peg patella 32mm ,(cn: 204-04-21, sn: (b)(4)) trapezoid tibial tray sz 1f/1t, 2f/1t , (cn: 230-02-02, sn: (b)(4)) optetrak asy, cr cemented femoral, sz 2.
Event or Problem Description
Surgeon revised knee due to poly wear and pcl failure.Surgeon removed all exactech components, implanting a stryker revision knee.Rep was not at case.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Section h10: the evaluation noted the revision reported was likely the result of excessive wear of the polyethylene tibial insert and the patient¿s reported pcl failure.The cause of the prosthesis wear cannot be determined because the component was not returned for evaluation.(d11) concomitant device(s): concomitant devices: (cn: (b)(4), sn: (b)(6) three peg patella 32mm.(cn: (b)(4), sn: (b)(6) trapezoid tibial tray sz 1f/1t, 2f/1t.(cn: (b)(4), sn: (b)(6) optetrak asy, cr cemented femoral, sz 2.

• Brand Name: OPTETRAK
• Common Device Name: CR TIBIAL INSERT SZ 2, 9MM, SLOPE +
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9279393
• Report Number: 1038671-2019-00561
• Device Sequence Number: 2733844
• Product Code: JWH
• UDI-Device Identifier: 10885862041029
• UDI-Public: 10885862041029
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2020

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: 06/05/2013
• Device Model Number: 200-62-09
• Device Catalogue Number: 200-62-09
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/18/2019
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 03/19/2020
• 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