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

Model Number 25MM GLENOID SPHERE CENTERED 36MM

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

Patient Problem Failure of Implant (1924)

Event Date 12/19/2020

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

During the surgical procedure when the doctor requested the (b)(4), (b)(4), the medical device had the screw blocked, preventing its proper implantation to the baseplate (b)(4).The surgeon tried to release the screw several times, due to this situation and that there was only one unit of this reference in the hospital, the doctor tries to implant this medical device in this state without being successful.The doctor (b)(6) decides apply for new the (b)(4) to implant it the patient.The surgeon decides to insert the eccentric glenoid sphere (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 60 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: 11271644
• MDR Text Key: 231577127
• Report Number: 3000931034-2021-00012
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386935824
• UDI-Public: 03700386935824
• 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: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25MM GLENOID SPHERE CENTERED 36MM
• Device Catalogue Number: DWD180
• Device Lot Number: AD1689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 01/08/2021
• Supplement Dates FDA Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 86 YR