MAUDE Adverse Event Report: EXACTECH, INC OPTETRAK TIBIAL TRAY, FINNED, CEMENTED

Catalog Number 200-04-21

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 09/21/2016

Event Type  Injury  

Manufacturer Narrative

The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, device specific information was not provided, precluding a review of the device history record.

Event Description

Index surgery: (b)(6) 2009.Revision of optetrak components due to pain.This event occurred outside of the us, in (b)(6), and was discovered as part of active surveillance.

Manufacturer Narrative

The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, device specific information was not provided, prexluding a review of the device history record.Engineering evaluation noted that the revision reported was likely the result of loosening, wear, or infection, which led to pain.

Event Description

Index surgery: (b)(6) 2009.Revision of optetrak components due to pain.This event occurred outside of the us, in (b)(6), and was discovered as part of active surveillance.

• Brand Name: OPTETRAK TIBIAL TRAY, FINNED, CEMENTED
• Type of Device: TIBIAL TRAY
• Manufacturer (Section D): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 6100503
• MDR Text Key: 59835059
• Report Number: 1038671-2016-00789
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 200-04-21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention