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

Model Number UNIVERSAL GLENOID - BASEPLATE MEDIUM

Device Problems Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

Patient Problem Ambulation Difficulties (2544)

Event Date 09/20/2019

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.It was reported that the facility is not releasing the device.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported the patient had a primary reverse total shoulder procedure on (b)(6) 2019.The patient returned to the or for a revision procedure on (b)(6) 2019 due to the implanted glenosphere disassociating from the baseplate.During the original procedure, the central screw depth gauge was used to ensure that the central screw was fully seated.After glenosphere impaction, the glenosphere forceps were used in multiple planes to ensure engagement of the morse taper.During the revision procedure the original glenosphere (ar-9120-02 / lot: 18.01057) and baseplate (ar-9504l-04 / lot: 18.00719) were explanted, and the surgeon implanted a mgs baseplate (ar-9560-28-2 / lot: 5642) and glenosphere (ar-9564-2842-lat / lot: 18.00802) in its place.The primary and revision procedure were performed by the same surgeon, and took place at the same facility.The following arthrex parts were implanted during the primary procedure: ar-9120-02 // lot: 18.01057 // qty.: 1, ar-9145-24 // lot: 18.00674 // qty.: 1, ar-9145-30 // lot: 18.01275 // qty.: 1, ar-9165-20nl // lot: 10247862 // qty.: 1, ar-9501-12p // lot: 18.00906 // qty/: 1, ar-9502f-42cpc // lot: 160037703 // qty.: 1, ar-9503l-03c // lot: 150044008 // qty.: 1, ar-9504l-04 // lot: 18.00719 // qty.: 1, ar-9550-06 // lot: 18.00623 // qty.: 1.The following arthrex parts were implanted during the revision procedure: ar-9503l-03c // lot: 18.00561 // qty.: 1, ar-9550-06 // lot: 18.00990 // qty.: 1, ar-9560-28-2 // lot: 5642 // qty.: 1, ar-9561-30s // lot: 6227 // qty.: 1, ar-9563-16 // lot: 2019000253 // qty.: 2, ar-9563-24 // lot: 2019001686 // qty.: 1, ar-9563-28 // lot: 2019001343 // qty.: 1, ar-9564-2842-lat // lot: 18.00802 // qty.: 1.Additional information received on 10/08/219: the rep reported the disassociation was first discovered from x-rays taken during an office visit on (b)(6) 2019.The rep is following up with the surgeon to discuss if the cause of the disassociation is known.The bone quality was hard.The rep stated the explanted devices were sent to pathology, and will not be returning to arthrex for evaluation.The following list is all of the arthrex parts that were explanted during the revision procedure: ar-9120-02 // lot: 18.01057, ar-9504l-04 // lot: 18.00719, ar-9145-24 // lot 18.00674, ar-9145-30 // lot 18.01275, ar-9165-20nl // lot 10247862, ar-9503l-03c // lot 150044008, ar-9550-06 // lot 18.00623.Additional information received on 10/09/2019: the rep confirmed no explanted implants have been discarded; rather, they have been sent to pathology.The rep has requested that the facility not discard the devices after the required 30 day hold.However, per the facility's policy the implants cannot be released without written consent from the patient.The request for the patient's consent to release the explanted devices will be introduced to the patient at their next follow-up visit which will take place in approximately four weeks.It was reported prior to the revision procedure and disassociation discovery the patient was experiencing a loss of mobility.

• Brand Name: UNIVERSAL GLENOID - BASEPLATE MEDIUM
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 9254820
• MDR Text Key: 169236410
• Report Number: 1220246-2019-01378
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867057357
• UDI-Public: 00888867057357
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142863
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/30/2019

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: 12/31/2023
• Device Model Number: UNIVERSAL GLENOID - BASEPLATE MEDIUM
• Device Catalogue Number: AR-9120-02
• Device Lot Number: 18.01057
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/07/2019
• Initial Date FDA Received: 10/30/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other