MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK HI-FLEX TIBIAL INSERT

Catalog Number 244-22-13

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Pain (1994)

Event Date 08/21/2014

Event Type  malfunction  

Event Description

Revision due to pain and loosening.During revision, it was noted there was no cement mantle on femur or tibial tray.

Manufacturer Narrative

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

• Brand Name: OPTETRAK HI-FLEX TIBIAL INSERT
• Type of Device: HI-FLEX TIBIAL INSERT
• 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: 4177441
• MDR Text Key: 5163055
• Report Number: 1038671-2014-00429
• 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: 09/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 244-22-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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