MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS SUTURE CUP, 39 (NEUTRAL); SHOULDR PROSTH HEMI- HUM UNCEM

Model Number	UNIVERS REVERS SUTURE CUP, 39 (NEUTRAL)
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that the invers shoulder prothesis was initially implanted on (b)(6) 2020.A crash on (b)(6) 2020, caused a periprosthetic fracture, which was treated conservatively.The fracture subsequently healed.The last images taken on (b)(6) 2022, showed that the implant was in the correct position.The x-rays taken on (b)(6) 2025, showed a fracture between the cup and the shaft.The implant was removed on (b)(6) 2025.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-9502f-39cpc arthrex univers revers¿ suture cup, batch 19.02222, was received for evaluation.Visual inspection revealed that the returned cup had the polyethylene cup still attached inside; therefore, the internal surface of the cup could not be inspected.Evaluation of the external surface noted scratches and dents, which are most likely associated with the implantation and explantation process.Additionally, the central screw was observed to be shorter than expected, indicating that the screw had fractured.The most likely cause of the reported failure is related to a patient-specific event.Directions for use dfu-0189-eu-01-eo - univers revers¿ shoulder prosthesis system.Adverse effects: 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.Loosening is frequently a consequence of one or several of the above listed risk conditions but can also be caused by inadequate anchoring technique (see below).Bone fractures as a result of one-sided overload or weakened bone substance.Precautions: patient weight.An overweight patient may present additional risk.Extreme stress or strain resulting from work or sport-related activity.Patients with increased risk of fractures due to repeated strain or trauma, or medical conditions that increase the patient's risk for trauma, including falls.

• Brand Name: UNIVERS REVERS SUTURE CUP, 39 (NEUTRAL)
• 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: 23956148
• Report Number: 1220246-2026-00029
• Device Sequence Number: 13164445
• Product Code: HSD
• UDI-Device Identifier: 00888867234222
• UDI-Public: (01)00888867234222(11)191001(17)240930(10)19.02222
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161782
• 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
• Report Date (Section B): 02/25/2026

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: 09/30/2024
• Device Model Number: UNIVERS REVERS SUTURE CUP, 39 (NEUTRAL)
• Device Catalogue Number: AR-9502F-39CPC
• Device Lot Number: 19.02222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2019
• 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