MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS HUMERAL STEM, SIZE 7; SHOULDR PROSTH HEMI- HUM UNCEM

Model Number	UNIVERS REVERS HUMERAL STEM, SIZE 7
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, a clindex notification was received indicating that a patient listed on the shoulder arthroplasty registry experienced loosening of the glenoid side implants on (b)(6) 2024.On (b)(6) 2024, the patient underwent revision surgery to have the baseplate removed and had a cta head implanted.This event was indicated to be related to the univer revers implant system implanted on (b)(6) 2023.No further information was provided.Additional information was received on 1/15/2025: the patient's initial procedure was on (b)(6) 2023, and an arthrex univers revers system was implanted.The patient suffered a fall around (b)(6) 2023, resulting in a medial body scapular fracture.An orif procedure was performed on (b)(6) 2024.No information was provided regarding the surgery on (b)(6) 2024.A post-operative x-ray and ct on (b)(6) 2024 confirmed that the medical aspect of the dural plating was intact, but the patient had a fracture distally over the acromion, which had not healed.X-rays on (b)(6)2024 also confirmed progressive loosening of the patient's reverse prosthesis, with a markedly anteverted glenoid baseplate.The acromion broke off and was sitting in the soft tissues of her posterior deltoid.On (b)(6) 2024, the patient underwent revision surgery to have the arthrex baseplate, the ar-9501-07p arthrex univers revers humeral stem, the ar-9501ftk univers revers fracture adapter trunion, and the ar-9501-fx6n univers revers fracture adapter removed.Additional information received on 2/7/2025: during the orif procedure on (b)(6) 2024, there were no arthrex products that were implanted or explanted.No further information was provided regarding this surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
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 is a patient-specific event.

• Brand Name: UNIVERS REVERS HUMERAL STEM, SIZE 7
• Common Device Name: SHOULDR PROSTH HEMI- HUM UNCEM
• 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: 21357525
• Report Number: 1220246-2025-00392
• Device Sequence Number: 8474544
• Product Code: HSD
• UDI-Device Identifier: 00888867247628
• UDI-Public: (01)00888867247628(11)230501(17)280430(10)22.04652
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K161782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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 Model Number: UNIVERS REVERS HUMERAL STEM, SIZE 7
• Device Catalogue Number: AR-9501-07P
• Device Lot Number: 24.00288
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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