MAUDE Adverse Event Report: ARTHREX, INC. 24MM BASEPLATE, 10 FULL AUGMENT; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number 24MM BASEPLATE, 10° FULL AUGMENT

Device Problems Loose or Intermittent Connection (1371); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/11/2021

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported that the surgeon was attempting to do a 10 degree augmented mgs glenoid with a 35mm central post.After impacting the glenosphere onto the baseplate, the patient's glenoid fractured and the entire construct came loose (see attached picture).The surgeon was not sure if they were too anterior with their initial guide pin and subsequent reaming, possibly weakening the bone anteriorly.The surgeon also went bi-cortical in the vault with the central post (b)(4)) and did not know if this ultimately led to the failure.The surgeon was able to use bone graft from the patient's resected humeral head to address the glenoid fracture and then implanted a non-augmented mgs baseplate and finished the procedure without further issue.

• Brand Name: 24MM BASEPLATE, 10 FULL AUGMENT
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 11946802
• MDR Text Key: 254805564
• Report Number: 1220246-2021-03216
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867341630
• UDI-Public: 00888867341630
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 24MM BASEPLATE, 10° FULL AUGMENT
• Device Catalogue Number: AR-9580-2410
• Device Lot Number: 952492026
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other