MAUDE Adverse Event Report: ARTHREX, INC. UNI GLENOID-PERIPHERAL LOCK SCRW; SHOULDR PROSTH, REVERSE CONFIG

Model Number	UNI GLENOID-PERIPHERAL LOCK SCRW
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a loosening of the eclipse prosthesis led to revision to univers revers.The following devices were initially implanted: eclipse head, eclipse trunion, eclipse cage screw and universal glenoid inlay.The universal glenoid had a good anchorage, so the pe was removed and a glenosphere was installed.On the humeral side an eclipse removed and univers revers installed.No further information received.Update on 03-oct-2023: further information was provided that the initial surgery was performed on (b)(6) 2017 and the following devices were implanted: ar-9145-30 lot: 160058310.Ar-9165-15 lot: 160064010.Ar-9120-01 lot: 160061912.Ar-9145-36 lot: 160058410 ar-9121-01 lot: 160101410 ar-9300-41cpc.
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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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.

• Brand Name: UNI GLENOID-PERIPHERAL LOCK SCRW
• Common Device Name: SHOULDR PROSTH, REVERSE CONFIG
• 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: emily shafer ; 8009337001
• MDR Report Key: 17995033
• Report Number: 1220246-2023-08331
• Device Sequence Number: 6754076
• Product Code: PHX
• UDI-Device Identifier: 00888867057739
• UDI-Public: 00888867057739
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: UNI GLENOID-PERIPHERAL LOCK SCRW
• Device Catalogue Number: AR-9145-36
• Device Lot Number: 160058410
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2023
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown