MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS SPACER 42+15MM; SHOULDR PROSTH, REVERSE CONFIG

Model Number	UNIVERS REVERS SPACER 42+15MM
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On 3/4/2025, a clindex notification was received indicating that a patient listed on the shoulder arthroplasty registry suffered loosening of humeral side implants.The patient suffered an injury after lifting a five-pound box.The x-rays indicated a small non-displaced fracture and loose humeral components.The patient underwent a revision rsa and ofif procedure on (b)(6) 2022.This event was indicated as unrelated to the universe reverse system implanted on (b)(6) 2020.No further information was reported.Additional information received on 3/19/2025: during the revision surgery on (b)(6) 2022 an ar-9564-2842-lat arthrex univers revers glenosphere, an ar-9563-16 univers revers peripheral screw, two ar-9563-24 univers revers peripheral screw, an ar-9562-32nl univers revers peripheral screw, an ar-9502f-42rcpc arthrex univers revers suture cup, an ar-9501-11p arthrex univers revers humeral stem, an ar-9550-15 arthrex univers revers spacer, and an ar-9503l-06c arthrex univers revers humeral insert was removed.The case was completed with new arthrex univers revers implants.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
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: UNIVERS REVERS SPACER 42+15MM
• 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: jared engle ; 8009337001
• MDR Report Key: 21774130
• Report Number: 1220246-2025-01235
• Device Sequence Number: 8079541
• Product Code: PHX
• UDI-Device Identifier: 00888867062344
• UDI-Public: (01)00888867062344(11)180829(17)230731(10)18.00989
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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: 07/31/2023
• Device Model Number: UNIVERS REVERS SPACER 42+15MM
• Device Catalogue Number: AR-9550-15
• Device Lot Number: 18.00989
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2018
• 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