MAUDE Adverse Event Report: TORNIER INC AEQUALIS PERFORM REVERSE SHOULDER SYSTEM; SHOULDER PROSTHESIS STD GLENOSPHERE, 39MM

Catalog Number DWJ013

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Patient Problem/Medical Problem (2688)

Event Date 12/02/2019

Event Type  Injury  

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.

Event Description

It was reported that subject: (b)(6) underwent revision surgery to correct issues with instability/dislocation.No other effects have been noted.

• Brand Name: AEQUALIS PERFORM REVERSE SHOULDER SYSTEM
• Type of Device: SHOULDER PROSTHESIS STD GLENOSPHERE, 39MM
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington, mn
• Manufacturer Contact: mary mcnabb ; 4375 e park 30 drive; columbia city, in ; 3713153
• MDR Report Key: 10173382
• MDR Text Key: 195747698
• Report Number: 3004983210-2020-00013
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/19/2020

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: Lay User/Patient
• Device Catalogue Number: DWJ013
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/03/2020
• Initial Date FDA Received: 06/19/2020
• 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: 71 YR