MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED GLENOID SPHERE; SHOULDER JOINT METAL PROSTHESIS

Model Number 2MM ECCENTRIC DIAMETER 36MM

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Failure of Implant (1924)

Event Date 10/26/2020

Event Type  malfunction  

Manufacturer Narrative

This is the initial 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 malfunction or is related to a death or injury.

Event Description

The first glenosphere couldn't be screwed, and the second glenosphere the connecting screw was tight.The surgeon used a third glenosphere and this one worked.By this issue the intervention took about 30 minutes longer.

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 malfunction or is related to a death or injury.

• Brand Name: AEQUALIS REVERSED GLENOID SPHERE
• Type of Device: SHOULDER JOINT METAL PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 10895000
• MDR Text Key: 217990240
• Report Number: 3000931034-2020-00148
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386935848
• UDI-Public: 03700386935848
• Combination Product (y/n): N
• PMA/PMN Number: K081059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2MM ECCENTRIC DIAMETER 36MM
• Device Catalogue Number: DWD182
• Device Lot Number: 4696AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other