MAUDE Adverse Event Report: TORNIER INC. AEQUALIS PERFORM REVERSE SHOULDER SYSTEM; SHOULDER PROSTHESIS ECCENTRIC GLENOSPHERE +3MM, 039MM

Catalog Number DWJ033

Device Problem Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 12/18/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during surgery the surgeon noted,"the notch on the implant is not long enough, so that when the glenosphere is inserted, the indentation is no longer visible, so that an accurate insertion is not possible." extra anesthesia time was necessary for the patient and about 30 minute surgical delay was incurred.

• Brand Name: AEQUALIS PERFORM REVERSE SHOULDER SYSTEM
• Type of Device: SHOULDER PROSTHESIS ECCENTRIC GLENOSPHERE +3MM, 039MM
• Manufacturer (Section D): TORNIER INC.; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: matt kennedy ; 10801 nesbitt ave s; bloomington, MN 55437 ; 9526837482
• MDR Report Key: 8195663
• MDR Text Key: 131382502
• Report Number: 3004983210-2018-00082
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DWJ033
• Device Lot Number: CZ0417173003
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2018
• 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