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

Model Number	AR-9121-02
Health Effect - Clinical Codes	Abrasion (1689); Failure of Implant (1924); Metal Related Pathology (4530)
Date of Event	06/22/2021
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that a revision surgery was performed due to an aseptic loosening of the device and a progressive polyethylene abrasion with pronounced metallosis.The complete shoulder prosthesis including humerus and glenoid components was changed to inverse shoulder prosthesis.
Additional Manufacturer Narrative
The reason for this supplemental submission is an update to change device part number from ar-9120-02 to ar-9121-02.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a patient-specific event that may occur due to fatigue wear of the implant.

• Brand Name: UNIVERSAL GLENOID - INLAY MEDIUM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): UNIVERSAL GLENOID - INLAY MEDIUM; 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: 12231613
• Report Number: 1220246-2021-03433
• Device Sequence Number: 19741785
• Product Code: PHX
• UDI-Device Identifier: 00888867057357
• UDI-Public: 00888867057357
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2024

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: 08/31/2019
• Device Model Number: AR-9121-02
• Device Catalogue Number: AR-9120-02
• Device Lot Number: 2501243304
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 07/07/2021; 08/22/2024
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 08/02/2021; 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown