MAUDE Adverse Event Report: ASCEND HUMERAL STEM SIZE 4A; 78MM 127.5; NONE

Catalog Number 503304A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 08/27/2014

Event Type  malfunction  

Event Description

Subluxation anterior; subluxation of prosthesis anteriorly on the axillary view with superior humeral migration on the static and dynamic resulting in revision to reverse shoulder arthroplasty on (b)(6) 2014.

Manufacturer Narrative

This is the initial report submitted regarding this surgical event and medical device.

• Brand Name: ASCEND HUMERAL STEM SIZE 4A; 78MM 127.5
• Type of Device: NONE
• Manufacturer Contact: kevin smith ; 10801 nesbitt ave s; bloomington, MN 55437 ; 9529217121
• MDR Report Key: 4628090
• MDR Text Key: 19316084
• Report Number: 3004983210-2015-00008
• Device Sequence Number: 1
• Product Code: KWH
• Combination Product (y/n): N
• PMA/PMN Number: 5110865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 503304A
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1