MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL INSERT L/42 +6 TO FIT IN 42 CUP; SHOULDR PROSTH, REVERSE CONFIG

Model Number	HUMERAL INSERT L/42 +6 TO FIT IN 42 CUP
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 11/3/2025, it was reported via email by a sales representative that an ar-9503l-06 arthrex univers revers humeral insert large was not seating properly in a 42 neutral suturecup.The surgeon noted that the taper did not appear to be engaging the suturecup correctly.After flushing both the suturecup and the humeral insert to rule out debris interference, the issue persisted.The surgeon then opened a new univers revers humeral insert, which seated properly without issue.This was discovered during an rtsa procedure on (b)(6) 2025.Additional information was received on 11/11/2025: on (b)(6) 2025, during an rtsa procedure, the surgeon encountered an issue with seating an ar-9503l-06 arthrex univers revers humeral insert (large) into an ar-9502f-42cpc arthrex univers revers suture cup, 42 (neutral).The taper on the insert did not appear to engage properly with the suture cup, and the taper was confirmed to be part of the insert.This occurred during the final implantation inside the patient.No component fractured inside the patient.To complete the case, the surgeon elected to use a spacer and a +3 polyethylene insert, suspecting the taper on the cup might have contributed to the seating issue.The spacer and insert fit appropriately.The final implanted components were ar-9550-06 arthrex univers revers spacer 42 + 6 mm and ar-9503l-03 arthrex univers revers humeral insert large / 42 / +3.The original ar-9502f-42cpc suture cup remained in use.There was no surgical delay, no additional anesthesia was required, and no photos were taken of the issue.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint device was not received for evaluation.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional field information, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is mechanical damage to one or both devices incurred during the setup process.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: HUMERAL INSERT L/42 +6 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: 23631091
• Report Number: 1220246-2025-05158
• Device Sequence Number: 18525807
• Product Code: PHX
• UDI-Device Identifier: 00888867061231
• UDI-Public: (01)00888867061231(11)230901(17)280831(10)23.00518
• 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
• Report Date (Section B): 03/10/2026

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 L/42 +6 TO FIT IN 42 CUP
• Device Catalogue Number: AR-9503L-06
• Device Lot Number: 23.00518
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown