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

Model Number 10° TILTED 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 08/27/2020

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 10° tilted sphere (reference dwd181, serial number (b)(4)), the medical device had the screw blocked, preventing its proper implantation to the threaded post baseplate (reference dwd725, serial number (b)(4)).The surgeon tried to release the screw several times without success.The doctor sanchez decides apply for the eccentric glenoid sphere (reference dwd182, serial number (b)(4)) to implant it the patient but had the same problem, the medical device had the screw blocked.The surgeon decides to insert the centered glenoid sphere, (reference dwd180, 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 40 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: 10612217
• MDR Text Key: 209384791
• Report Number: 3000931034-2020-00129
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386935831
• UDI-Public: 03700386935831
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 10° TILTED DIAM. 36MM FOR 25MM BASEPLATE
• Device Catalogue Number: DWD181
• Device Lot Number: 2984AV
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/04/2020
• Initial Date FDA Received: 10/01/2020
• Supplement Dates Manufacturer Received: 09/04/2020
• Supplement Dates FDA Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other