MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL SPACER 33+6MM; SHOULDR PROSTH, REVERSE CONFIG

Model Number	HUMERAL SPACER 33+6MM
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.
Event or Problem Description
On 6/26/2023, it was reported by a sales representative via email that a patient underwent a revision shoulder arthroplasty procedure on (b)(6) 2023 due to an infection and loosened baseplate.On (b)(6) 2023, the patient complained of pain after the original procedure on (b)(6) 20203.During the post-operative visit, radiographs indicated a loosened baseplate, but the infection type was not yet confirmed.During the revision surgery, an ar-9564-2433-lat glenosphere, an ar-9580-2420 baseplate, an ar-9582-20 modular post, an ar-9501-10s humeral stem, an ar-9502f-33cpc suture cup, an ar-9503xs-03 humeral insert, an ar-9504-06 humeral spacer, an ar-9562-24nl peripheral non-locking screw, an ar-9563-16 peripheral locking screw, an ar-9563-20 peripheral locking screw, and ar-9563-24 peripheral locking screw were explanted.The case was completed by taking cultures for further testing and placing antibiotic spacers.No additional arthrex products were implanted.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint is confirmed based on the x-ray provided from the field.Consequently, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a patient-specific event.

• Brand Name: HUMERAL SPACER 33+6MM
• 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: emily shafer ; 8009337001
• MDR Report Key: 17363965
• Report Number: 1220246-2023-07234
• Device Sequence Number: 17665103
• Product Code: HSD
• UDI-Device Identifier: 00888867406902
• UDI-Public: 00888867406902
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K221232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: HUMERAL SPACER 33+6MM
• Device Catalogue Number: AR-9504-06
• Device Lot Number: 22.00731
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2023
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2022
• 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