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

Model Number	25MM 2MM ECCENTRIC 36MM
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.
Event or Problem 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.
Additional 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
• Common Device Name: SHOULDER JOINT METAL PROSTHESIS
• MDR Report Key: 9675530
• Report Number: 3000931034-2020-00006
• Device Sequence Number: 11456652
• Product Code: KWS
• UDI-Device Identifier: 03700386935848
• UDI-Public: 03700386935848
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K081059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/05/2024
• Device Model Number: 25MM 2MM ECCENTRIC 36MM
• Device Catalogue Number: DWD182
• Device Lot Number: 2565AU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 05/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other