MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS HUMERAL STEM, SIZE 12; SHOULDR PROSTH HEMI- HUM UNCEM

Model Number	UNIVERS REVERS HUMERAL STEM, SIZE 12
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/15/2025
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 a patient underwent multiple surgeries on the reported shoulder prosthesis.It was further reported that some revision surgeries have been performed.It was further reported that the customer has in addition to the reported devices five screws (1 silver, 3 green, 1 purple), a base plate, glenosphere, an inlay and a post.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-9501-12p univers revers¿ humeral stem, size 12 batch number: 22.02265 was received for investigation.Visual evaluation noted superficial scratches and discoloration to the returned device.Functional testing was performed by assembling the returned device with the returned mating devices.No issues were noted when the devices were assembled together.The most likely cause for the reported failure can be attributed to a patient-specific event.

• Brand Name: UNIVERS REVERS HUMERAL STEM, SIZE 12
• 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: 21323145
• Report Number: 1220246-2025-00266
• Device Sequence Number: 18122119
• Product Code: HSD
• UDI-Device Identifier: 00888867250444
• UDI-Public: 00888867250444
• 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): 04/09/2025

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 12
• Device Catalogue Number: AR-9501-12P
• Device Lot Number: 22.02265
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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