MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; CEMENTED FINNED TIB. TRA SZ 2F/3T

Model Number	SPECIFIC DEVICE NOT REPORTED
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical devices: (cn: 200-02-35, sn: (b)(4)) three peg patella 35mm.(cn: 232-03-02, sn: (b)(4)) optetrak asy, cr porous femoral, sz 2, right.
Event or Problem Description
As reported, there was narrowing of the joint space on the medial side on the right knee noted on an x-ray of a (b)(6) y/o female patient.During exposure there was evidence of osteolysis scratching of the femoral component complete wear of the poly insert and a worn hole in the tibial tray.Patient was last known to be in stable condition following the event.Patient was last known to be in stable condition following the event.Devices not returning, disposed of by facility.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted in the revision reported was likely the combination of the posterior tibial slope and the slope ++ tibial insert which allowed for excessive posterior contact between the femoral component and the tibial insert, especially medially, and led to the reported wear of the polyethylene.The wear likely led to metal on metal contact between the femoral component and tibial tray which resulted in the reported scratches of the femoral component, and a worn hole in the tibial tray.However, this cannot be confirmed as the devices were not available for evaluation.(d11) concomitant devices: - (cn: (b)(6) sn: (b)(6) ) three peg patella 35mm.- (cn: (b)(6) sn: (b)(6) ) optetrak asy, cr porous femoral, sz 2, right.

• Brand Name: OPTETRAK
• Common Device Name: CEMENTED FINNED TIB. TRA SZ 2F/3T
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10219895
• Report Number: 1038671-2020-00327
• Device Sequence Number: 3233637
• Product Code: JWH
• UDI-Device Identifier: 10885862039712
• UDI-Public: 10885862039712
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

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: 11/13/2016
• Device Model Number: SPECIFIC DEVICE NOT REPORTED
• Device Catalogue Number: 200-04-23
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 08/18/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR