MAUDE Adverse Event Report: TORNIER INC AEQUALIS PERFORM REVERSE SHOULDER SYSTEM; SHOULDER PROSTHESIS STD GLENOSPHERE 42MM

Catalog Number DWJ014

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 04/04/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

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

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.This submission does not constitute a determination or admission that a device has malfunctioned or is related to a death or injury.

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 42MM
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• MDR Report Key: 8651445
• MDR Text Key: 146419385
• Report Number: 3004983210-2019-00019
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• PMA/PMN Number: K161742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 05/29/2019

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 Expiration Date: 02/06/2024
• Device Catalogue Number: DWJ014
• Device Lot Number: CZ1519010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/15/2019
• Initial Date FDA Received: 05/29/2019
• Supplement Dates Manufacturer Received: 05/15/2019
• Supplement Dates FDA Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PERFORM REV HALF-WEDGE BASEPLATE, 25MM.
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR