MAUDE Adverse Event Report: ARTHREX, INC. USP II HUMERAL HEAD 44/19; PROSTHESIS, SHOULDER, CEMENTED

Model Number	USP II HUMERAL HEAD 44/19
Medical Device Problem Codes	Use of Device Problem (1670); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 06/09/2025, a sales representative reported via email that an ar-9144-19p arthrex univers ii 3d humeral head trial size lost stability after the implant was opened.They switched to a larger implant size, which restored the required stability.This was discovered during a procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 06/25/2025: this occurred during an anatomic total shoulder procedure on (b)(6) 2025.The ar-9146-20p arthrex univers ii 3d humeral head, 46/20 was used to complete the case.No case delay or added anesthesia was administered to the patient.No adverse effects were reported during or after the surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.-one unpackaged ar-9144-19p, humeral head, 44/19, batch number 15307194 was received for investigation.-visual inspection noted signs of surface damage along the body of the device, likely from the implantation and explantation process.- functional testing was not performed due to the damage to the device.- the most likely cause of the reported failure is user error, which involved selecting an incorrect implant size.- no problem found.-refer to investigation photos.-the complaint allegation is not confirmed.

• Brand Name: USP II HUMERAL HEAD 44/19
• Common Device Name: PROSTHESIS, SHOULDER, CEMENTED
• 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: 22397319
• Report Number: 1220246-2025-02730
• Device Sequence Number: 4941296
• Product Code: KWS
• UDI-Device Identifier: 00888867057708
• UDI-Public: (01)00888867057708(11)240826(17)290731(10)15307194
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K071032
• 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): 09/25/2025

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: USP II HUMERAL HEAD 44/19
• Device Catalogue Number: AR-9144-19P
• Device Lot Number: 15307194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 06/09/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown