MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL INSERT S/36 +6 TO FIT IN 36 CUP; SHOULDR PROSTH, REVERSE CONFIG

Model Number	HUMERAL INSERT S/36 +6 TO FIT IN 36 CUP
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 25-feb-2026, a sales representative reported via phone that an ar-9503s-06 arthrex univers revers humeral insert small / 36 / +6 would not seat within the ar-9502f-36lcpc arthrex univers revers suture cup, 36 (+2 left).The inserter was removed, and another ar-9503s-06 humeral insert from the same lot was used with the original suture cup without issue.No breakage occurred.There was no case delay or additional anesthesia time.The event was identified during a reverse total shoulder procedure on (b)(6) 2026.No patient harm 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 S/36 +6 TO FIT IN 36 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: 24620574
• Report Number: 1220246-2026-01472
• Device Sequence Number: 21366744
• Product Code: PHX
• UDI-Device Identifier: 00888867061316
• UDI-Public: 00888867061316
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 07/08/2026

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 Model Number: HUMERAL INSERT S/36 +6 TO FIT IN 36 CUP
• Device Catalogue Number: AR-9503S-06
• Device Lot Number: 24.02165
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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