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

Model Number UNIVERSAL GLENOID - INLAY MEDIUM

Device Problem Degraded (1153)

Patient Problem Metal Related Pathology (4530)

Event Date 02/23/2022

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.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported that a revision surgery was necessary due to a progressive polyethylene degradation with metallosis.No further information was provided.

Manufacturer Narrative

The complaint cannot be confirmed based on the customer provided photos, which are unclear to conclude that the material has degraded.However, without return of the device for physical evaluation, the cause remains undetermined.No change in harm was identified.

• Brand Name: UNIVERSAL GLENOID - INLAY 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: 13839577
• MDR Text Key: 287575684
• Report Number: 1220246-2022-04620
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867057425
• UDI-Public: 00888867057425
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K182039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 07/29/2022

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: 10/31/2017
• Device Model Number: UNIVERSAL GLENOID - INLAY MEDIUM
• Device Catalogue Number: AR-9121-02
• Device Lot Number: 2501257904
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/28/2022
• Initial Date FDA Received: 03/21/2022
• Supplement Dates Manufacturer Received: 02/28/2022
• Supplement Dates FDA Received: 07/29/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other