MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE HUMERAL ADAPTER X-RAY

Catalog Number 320-10-00

Device Problem Insufficient Information (3190)

Patient Problem Arthritis (1723)

Event Type  Injury  

Event Description

Revision due to septic arthritis.

Manufacturer Narrative

This event report was received through clinical data collection activities.The contribution of the devices to the experience reported could not be determined as the devices were not returned for eval.

• Brand Name: EQUINOXE REVERSE HUMERAL ADAPTER X-RAY
• Type of Device: REVERSE HUMERAL ADAPTER X-RAY
• Manufacturer (Section D): EXACTECH, INC.; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 n.w. 66th ct.; gainesville, FL 32653
• MDR Report Key: 3981478
• MDR Text Key: 4632592
• Report Number: 1038671-2014-00300
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-10-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/25/2014
• 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; Other
• Patient Age: 68 YR
• Patient Weight: 98