MAUDE Adverse Event Report: AEQUALIS REVERSED GLENOID SPHERE; SHOULDER JOINT METAL PROSTHESIS

Model Number 25MM 2MM ECCENTRIC 36MM

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During total arthroplasty surgery, the surgeon was not able to impact the glenoid sphere on the baseplate (impossibility to screw the sphere).Second try with another glenoid eccentric sphere (same reference - (b)(4) - other batch number: 0993av001).Again, the glenoid sphere could not be screwed.Use of a third glenoid sphere (centered) with another screwdriver to complete the surgery.

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
• MDR Report Key: 9675532
• MDR Text Key: 177932446
• Report Number: 3000931034-2020-00007
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

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: 25MM 2MM ECCENTRIC 36MM
• Device Catalogue Number: DWD182
• Device Lot Number: 0993AV
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/10/2020
• Initial Date FDA Received: 02/06/2020
• Supplement Dates Manufacturer Received: 01/10/2020
• Supplement Dates FDA Received: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other