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

Model Number UNIVERS VAULTLOCK GLENOID TRIAL, LARGE

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 03/29/2021

Event Type  malfunction  

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 Description

It was reported during a total shoulder eclipse the trials became impacted in the glenoid and it was very hard to remove and broke.All was retrieved.The case was completed with no further issues and the patient is fine to date.

• Brand Name: UNIVERS VAULTLOCK GLENOID TRIAL, LARGE
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 11687422
• MDR Text Key: 248533302
• Report Number: 1220246-2021-02906
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00888867250697
• UDI-Public: 00888867250697
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161108
• 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: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNIVERS VAULTLOCK GLENOID TRIAL, LARGE
• Device Catalogue Number: AR-9236-03PP
• Device Lot Number: 1027262101
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/29/2021
• Initial Date FDA Received: 04/19/2021
• Date Device Manufactured: 01/11/2021
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1