MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL INSERT L/42 +3 TO FIT IN 42 CUP; SHOULDR PROSTH, REVERSE CONFIG

Model Number	HUMERAL INSERT L/42 +3 TO FIT IN 42 CUP
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 2/24/2025, it was reported by a sales representative via email that an ar-9503l-03 arthrex univers revers humeral insert was not seating properly in the suturecup.The surgeon was concerned that the taper was not engaging with the cup properly.The surgeon confirmed there was no debris in the cup and cleaned off the humeral insert but it still could not engage.This was discovered during a revers total shoulder procedure on (b)(6) 2025.Additional information requested on 3/3/2025.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
Event or Problem Description
Additional information was received on 3/6/2025: the part number for the suturecup is an ar-9502f-42cpc.Nothing broke inside the patient.The case was completed by using an ar-9503l-06 arthrex univers revers humeral insert with the same ar-9502f-42cpc arthrex univers revers suturecup.The case was not delayed, and additional anesthesia was not needed.
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 user error of the device due to user-applied mechanical forces during insertion/extraction of the device.

• Brand Name: HUMERAL INSERT L/42 +3 TO FIT IN 42 CUP
• 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: 21582361
• Report Number: 1220246-2025-00880
• Device Sequence Number: 8832675
• Product Code: PHX
• UDI-Device Identifier: 00888867061217
• UDI-Public: (01)00888867061217(11)211201(17)261130(10)21.02578
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HUMERAL INSERT L/42 +3 TO FIT IN 42 CUP
• Device Catalogue Number: AR-9503L-03
• Device Lot Number: 21.02578
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: Not provided; 08/27/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 03/20/2025; 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2021
• 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
• Patient Sex: Unknown