MAUDE Adverse Event Report:; GLENOID, HEAD W/RETAINING SCREW, RSP, 32MM/-4MM

Catalog Number 508-32-103

Device Problem Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Corrected data: original initial report was submitted as follow up in error.

Event Description

Revision surgery - the patient had a reverse shoulder done on (b)(6) 2014, and has experienced some notching on the inferior side of the glenoid.The surgeon believes the baseplate was not placed inferior enough, therefore causing the notching.The surgeon removed the 32 -4 glenosphere, and replaced it with a 32 neutral glenosphere to provide more lateralization.He also replaced the 32 neutral socket insert due to wear on the previous implant.He believed this would help limit the notching.

• Type of Device: GLENOID, HEAD W/RETAINING SCREW, RSP, 32MM/-4MM
• MDR Report Key: 10806494
• MDR Text Key: 215263144
• Report Number: 1644408-2016-00962
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 11/05/2020

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: No Information
• Device Catalogue Number: 508-32-103
• Device Lot Number: 864C1502
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/08/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention