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

Model Number CENTERED DIAM. 36MM FOR 25MM BASEPLATE

Device Problems Device Difficult to Setup or Prepare (1487); Mechanical Jam (2983)

Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/29/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During the surgical procedure when the doctor requested the centered glenoid sphere (reference (b)(4), serial number (b)(4)), the medical device had the screw blocked, preventing its proper implantation to the baseplate (reference (b)(4), serial number (b)(4)).The surgeon tried to release the screw several times without success.He decides apply for new the glenosphere to implant it the patient.The surgeon decides to insert the eccentric glenoid sphere (reference (b)(4), serial number (b)(4)).The surgery ends without serious events, and the patient does not have any problem or serious impact.This event implied that the anesthesia time was extend for a period of 20 minutes.

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: 10612092
• MDR Text Key: 209350365
• Report Number: 3000931034-2020-00128
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386935824
• UDI-Public: 03700386935824
• Combination Product (y/n): Y
• 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: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CENTERED DIAM. 36MM FOR 25MM BASEPLATE
• Device Catalogue Number: DWD180
• Device Lot Number: AD1604
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR