MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH FEMORAL COMPONENT

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

Revision of optetrak cr insert with finned tibial tray, due to tibial loosening.

Manufacturer Narrative

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

• Brand Name: EXACTECH FEMORAL COMPONENT
• Type of Device: FEMORAL COMPONENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 n.w. 66th ct.; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 n.w. 66th ct.; gainesville, FL 32653
• MDR Report Key: 4357917
• MDR Text Key: 5111690
• Report Number: 1038671-2014-00659
• Device Sequence Number: 1
• Product Code: KXA
• 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: 12/16/2014

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/21/2014
• Initial Date FDA Received: 12/16/2014
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention