MAUDE Adverse Event Report: ARTHREX, INC. UNIVERSAL GLENOID - BASEPLATE SMALL; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	UNIVERSAL GLENOID - BASEPLATE SMALL
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/27/2020
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
It was reported that a patient had a reverse shoulder replacement performed on (b)(6) 2015.The peripheral screws on the baseplate had broken requiring the patient to have a revision surgery (b)(6) 2020 at a different facility.The glenoid components were revised and the implant was replaced with an mgs glenoid baseplate.Explanted devices were discarded by the facility at time of procedure.The following original implants were explanted: ar-9120-01 glenoid baseplate lot 140122110, ar-9145-30 uni glenoid peripheral locking screw lot 150018908, ar-9145-24 uni glenoid peripheral locking screw lot 140123008.Additional information obtained 12/1/20: the patient did not suffer any trauma or fall prior to the revision.The surgeon noted the patient was an active golfer and tennis player.

• Brand Name: UNIVERSAL GLENOID - BASEPLATE SMALL
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11046491
• Report Number: 1220246-2020-02417
• Device Sequence Number: 1193601
• Product Code: PHX
• UDI-Device Identifier: 00888867057340
• UDI-Public: 00888867057340
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/21/2020

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: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: UNIVERSAL GLENOID - BASEPLATE SMALL
• Device Catalogue Number: AR-9120-01
• Device Lot Number: 140122110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 12/21/2020
• 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