MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS VAULTLOCK GLENOID, SMALL; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	UNIVERS VAULTLOCK GLENOID, SMALL
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/05/2018
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 device was reported to have been discarded.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that on (b)(6) 2017, the patient underwent a revers tsa procedure where a univers apex humeral stem, ar-9100-05s, lot: 10036035; a uspii humeral head, ar-9142-17p, lot: 150030015; and a univers vaultlock glenoid, ar-9106-01, lot: 1027261549, were implanted.In (b)(6) 2018, about 1 year post-op, the patient had a follow up appointment with his surgeon to see the progress of the tsa.An x-ray was taken and the surgeon determined that the glenoid had failed and a revision surgery would be needed.On (b)(6) 2018, a revision rtsa procedure was performed where all three of the implanted devices were explanted and replaced with an arthrex rtsa system.The explanted hardware was discarded.

• Brand Name: UNIVERS VAULTLOCK GLENOID, SMALL
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7902215
• Report Number: 1220246-2018-00665
• Device Sequence Number: 11159533
• Product Code: KWS
• UDI-Device Identifier: 00888867239319
• UDI-Public: 00888867239319
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K161108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/24/2018

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: 04/30/2021
• Device Model Number: UNIVERS VAULTLOCK GLENOID, SMALL
• Device Catalogue Number: AR-9106-01
• Device Lot Number: 1027261549
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 09/24/2018
• 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