MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS ¿GLENOSPHERE CON 5MM¿; TITAN SHOULDER SYSTEM

Catalog Number ¿GLS-0960-05C¿

Device Problem Failure To Adhere Or Bond (1031)

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

Event Type  malfunction  

Manufacturer Narrative

Integra has completed their internal investigation on april 6, 2017.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaints history.Results: evaluation of returned device; the explanted device was returned and evaluated by the receiving inspector and r/d engineer.A visual exam of the device was conducted and no surface damage or abnormalities were noted.No nonconformance was identified.The supplier inspection data for this lot was within acceptable limits.Visual inspection using a visual comparator, found no discrepancies.Dhr review; no anomalies or nonconformances were identified that could have cause or contributed to the reported complaint complaints history; a review of complaint records showed that since product inception in 2013, 1 complaint has been received for seating issues of the glenosphere identified in mid-surgery.During this period of time, there have been 2232 rss surgeries performed.This represents 0.04% (1/2232) failure rate.Conclusion: the root cause of this issue could not be determined, but previous investigations identified the following potential causes for the glenosphere dislocation, disassociation or loosening: insufficient impaction while seating the glenosphere during the initial surgery or failure to follow surgical technique.Improper bone preparation of humeral canal.Improper bone preparation of glenoid.Improper implant size selection by user.

Event Description

It was reported that the glenosphere failed to seat properly.A new glenosphere was opened and did seat properly.No patient injury and the event did not lead to surgical delay.

• Brand Name: ¿GLENOSPHERE CON 5MM¿
• 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: 6499771
• MDR Text Key: 73069188
• Report Number: 1651501-2017-00014
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K130050
• 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: 02/15/2017

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ¿GLS-0960-05C¿
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2017
• Initial Date Manufacturer Received: 04/06/2017
• Initial Date FDA Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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