MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK ALL POLY TIBIAL COMPONENT

Device Problems Fracture (1260); Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Revision of knee components due to tibial loosening and a fractured anterior tibia with the insertion of a stemmed tibia.This event report was received through clinical data collection activities.

Manufacturer Narrative

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

• Brand Name: OPTETRAK ALL POLY TIBIAL COMPONENT
• Type of Device: ALL POLY TIBIAL COMPONENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th ct.; gainesville, FL 32653
• MDR Report Key: 3889092
• MDR Text Key: 20299148
• Report Number: 1038671-2014-00268
• Device Sequence Number: 1
• Product Code: HSH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2014
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention