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

Model Number	UNIVERSAL GLENOID - INLAY MEDIUM
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377)
Date of Event	02/13/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
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 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.

• Brand Name: UNIVERSAL GLENOID - INLAY MEDIUM
• Common Device Name: 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: 13053843
• Report Number: 1220246-2021-04127
• Device Sequence Number: 1426898
• Product Code: PHX
• UDI-Device Identifier: 00888867057425
• UDI-Public: 00888867057425
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K182039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/21/2021

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: 04/30/2017
• Device Model Number: UNIVERSAL GLENOID - INLAY MEDIUM
• Device Catalogue Number: AR-9121-02
• Device Lot Number: 2501210204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 12/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown