MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS TITAN REVERSE SHOULDER SYSTEM, UNKNOWN; TITAN SHOULDER SYSTEM

Catalog Number XXX-RSS

Device Problems Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 10/26/2017

Event Type  Injury  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

It was reported that the glenosphere on patient's reverse total shoulder prosthesis disengaged from the baseplate and needed revision surgery to replace it.

Manufacturer Narrative

Integra has completed their internal investigation on november 28, 2017.Results: dhr review; the complaint report does not include the device lot number; therefore, a dhr review could not be conducted.Complaints history; a review of complaint records showed that since product inception in 2013, 17 complaints have been received for gls-0960-xx glenosphere disassociation, disengagement or loosening.During this period of time, there have been 3052 rss surgeries performed.This represents 0.55% (17/3052) overall failure rate with highest severity being serous.An adverse trend has been identified conclusion: the device was not returned.

• Brand Name: TITAN REVERSE SHOULDER SYSTEM, UNKNOWN
• Type of Device: TITAN SHOULDER SYSTEM
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX 78754
• Manufacturer (Section G): ASCENSION ORTHOPEDICS; 8700 cameron road #100; austin TX 78754
• Manufacturer Contact: sonia irizarry ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7046293
• MDR Text Key: 92544178
• Report Number: 1651501-2017-00044
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• PMA/PMN Number: K130050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-RSS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/01/2017
• Initial Date FDA Received: 11/20/2017
• Supplement Dates Manufacturer Received: 11/28/2017
• Supplement Dates FDA Received: 12/13/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention