MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS GLENO 39 + 4 LAT; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	UNIVERS REVERS GLENO 39 + 4 LAT
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received but has not yet been evaluated.Once evaluated, a supplemental report will be submitted.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 the patient underwent a revers total shoulder arthroplasty procedure on (b)(6) 2018 where a univers glenoid, ar-9504m-04 and a humeral insert, ar-9503m-06, were implanted.Post-op, the glenosphere disassociated from the baseplate and was revised with a new glenosphere.Additional details provided (b)(6) 2019: the revision took place on (b)(6) 2019.The patient did not report any trauma to the surgeon however the surgeon stated that the disassociation occurred during physical therapy.
Additional Manufacturer Narrative
Complaint was not confirmed.Dimensional analysis of returned device confirms device meets specifications and critical mating features (morse taper) are within tolerance.No significant damage noted to device.As the baseplate was not returned for evaluation the condition of the mating surface is unknown.Based on the device evaluation, the cause of the event is undetermined however, a most likely cause is as stated in the complainant's narrative that the disassociation occurred during physical therapy.

• Brand Name: UNIVERS REVERS GLENO 39 + 4 LAT
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8381724
• Report Number: 1220246-2019-00928
• Device Sequence Number: 1955311
• Product Code: PHX
• UDI-Device Identifier: 00888867061378
• UDI-Public: 00888867061378
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2019

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: 06/30/2023
• Device Model Number: UNIVERS REVERS GLENO 39 + 4 LAT
• Device Catalogue Number: AR-9504M-04
• Device Lot Number: 18.00604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 03/27/2019
• 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