MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; PS TIBIAL INSERTS SZ 4, 11MM

Model Number	204-24-11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
Revision reason not reported.The surgeon opened the knee in standard fashion.The surgeon took out the 11 mm poly liner and replaced it with a 15 mm poly.This gave the patient better stabilization.The surgeon then closed the knee in standard fashion.Patient was last known to be in stable condition following the event.
Event or Problem Description
Approximately 9 years postoperatively a tka, a 75 y/o male patient was revised.The surgeon took out the 11mm poly liner and replaced it with a 15mm poly.This gave the patient better stabilization.The surgeon then closed the knee in standard fashion.Patient was last known to be in stable condition following the event.The devices were disposed of by the hospital.Upon review of all available information, there is no evidence to suggest that a design or manufacturing issue caused or contributed to this event.The reported revision was likely the result of underlying patient factors, which led to instability of the joint.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that approximately 9 years postoperatively a tka, a 75 y/o male patient was revised.The surgeon took out the 11mm poly liner and replaced it with a 15mm poly.This gave the patient better stabilization.The surgeon then closed the knee in standard fashion.Patient was last known to be in stable condition following the event.The devices were disposed of by the hospital.Upon review of all available information, there is no evidence to suggest that a design or manufacturing issue caused or contributed to this event.The reported revision was likely the result of underlying patient factors, which led to instability of the joint.No information provided in the following section(s): a4, a5, and b6.The following section(s) have additional info; b5, g4, g7, h1, h2, h3, h6, and h7.

• Brand Name: OPTETRAK
• Common Device Name: PS TIBIAL INSERTS SZ 4, 11MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9307770
• Report Number: 1038671-2019-00565
• Device Sequence Number: 18949596
• Product Code: JWH
• UDI-Device Identifier: 10885862048394
• UDI-Public: 10885862048394
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2020

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: 08/20/2016
• Device Model Number: 204-24-11
• Device Catalogue Number: 204-24-11
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 04/29/2020
• 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: 75 YR