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

Model Number UNIVERS REVERS GLENO 39 + 4 LAT

Device Problem Material Disintegration (1177)

Patient Problem No Information (3190)

Event Date 02/07/2019

Event Type  Injury  

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 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.

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
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8381724
• MDR Text Key: 137523976
• Report Number: 1220246-2019-00928
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867061378
• UDI-Public: 00888867061378
• Combination Product (y/n): N
• PMA/PMN Number: K142863
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 02/07/2019
• Initial Date FDA Received: 03/01/2019
• Supplement Dates Manufacturer Received: 02/07/2019
• Supplement Dates FDA Received: 03/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other