MAUDE Adverse Event Report: EXACTECH, INC. EQUINOX STANDARD REVERSE HUMERAL LINER

Catalog Number 320-46-03

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/04/2014

Event Type  malfunction  

Event Description

Revision due to rotator cuff tear.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 eval.Additionally, the device specific info was not provided, precluding a review of the device history record.

• Brand Name: EQUINOX STANDARD REVERSE HUMERAL LINER
• Type of Device: STANDARD REVERSE HUMERAL LINER
• 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: 4185522
• MDR Text Key: 5094222
• Report Number: 1038671-2014-00359
• Device Sequence Number: 1
• Product Code: KWT
• 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
• Report Date: 07/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-46-03
• 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
• Patient Age: 86 YR
• Patient Weight: 47