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

Model Number UNIVERSAL GLENOID - BASEPLATE MEDIUM

Device Problems Break (1069); Output Problem (3005); Noise, Audible (3273)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377)

Event Date 02/13/2020

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.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported that a revision surgery was performed on the (b)(6) 2020 due to polyethylene abrasion in combination with metallosis and osteolysis.The initial surgery took place in (b)(6) 2016.From summer 2019 on the patient suffered from pain, restriction of shoulder movement, and a strong squeaking noise occurred when moving the shoulder.During the revision surgery it was noticed that the devices didn`t show any sign of loosening and the position was still correct.The polyethylene part of the device showed a high pe consumption and is massively thinned out.In the free joint space, a broken off part of the polyethylene was found.Osteolysis could be observed at the upper glenoid pole of approx.One cubic centimeter to the proximal screw caused by the metallosis.The patient was treated by replacing the polyethylene inlay with a new one of size medium.Removal of the old an application of a new anti-allergenic eclipse dome as usual of size 47/16.In addition a resection of any metallic altered soft tissue as well as synovial tissue was performed.The surgery was finished successfully.The patient reports a permanent limitation of movement since the incident.

• 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: 13053756
• MDR Text Key: 283093012
• Report Number: 1220246-2021-04126
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867057357
• UDI-Public: 00888867057357
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142863
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: UNIVERSAL GLENOID - BASEPLATE MEDIUM
• Device Catalogue Number: AR-9120-02
• Device Lot Number: 2501325907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other