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

Model Number	UNIVERSAL GLENOID INLAY SMALL
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/12/2022
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 necessary due to an aseptic loosening, inlay is abraded and a reconstruction with pelvoplasty.An inverse prosthesis is also planned.The event required a stationary treatment and results in another.
Event or Problem Description
It was reported that a revision surgery is necessary due to an aseptic loosening, inlay is abraded and a reconstruction with pelvoplasty.An inverse prosthesis is planned.The event required a stationary treatment and results in another.No further information received.05-jul-2023 update dw further information were provided that the revision surgery was performed on (b)(6) 2023 with an implantation of inverse shoulder prosthesis.The customer further provided the information that the reported device is now available for evaluation.
Additional Manufacturer Narrative
Additional info: 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.
Additional Manufacturer Narrative
Corrected information: h1.Additional information: d9, g3, h3, h6.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional information from the field, arthrex concluded that the most likely cause.The reported failure is most likely due to a patient-specific event, particularly the loosening of the implant as a result of changed conditions in load transfer, respectively, fatigue wear and breakage of the cement bed, and/or tissue reaction to the implant.The complaint was confirmed based on the attached pictures and the received devices.Due to the biohazard condition, they were unable to be physically and visually evaluated.

• Brand Name: UNIVERSAL GLENOID INLAY SMALL
• 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: 15806967
• Report Number: 1220246-2022-05766
• Device Sequence Number: 12168155
• Product Code: PHX
• UDI-Device Identifier: 00888867057418
• UDI-Public: 00888867057418
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2025

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: 02/28/2017
• Device Model Number: UNIVERSAL GLENOID INLAY SMALL
• Device Catalogue Number: AR-9121-01
• Device Lot Number: 2501203103
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2022
• Supplement Date Received by Manufacturer: 10/24/2022; 05/06/2025
• Initial Report FDA Received Date: 11/16/2022
• Supplement Report FDA Received Date: 09/28/2023; 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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