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	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 31-aug-2026, a sales representative reported via email that an ar-9503l-03 arthrex univers revers humeral insert large / 42 / +3 would not connect with the suture cup during a reverse shoulder procedure performed on (b)(6) 2026.The surgeon opened another humeral liner, which successfully mated with the suture cup.No harm to the patient was reported.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• 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 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50758592
• Report Number: 1220246-2026-04714
• Device Sequence Number: 9631632
• Product Code: PHX
• UDI-Device Identifier: 00888867061217
• 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
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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 Expiration Date: 08/31/2026
• Device Model Number: HUMERAL INSERT L/42 +3 TO FIT IN 42 CUP
• Device Catalogue Number: AR-9503L-03
• Device Lot Number: 21.01830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2021
• 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