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

Model Number HUMERAL SPACER 33+6MM

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Unspecified Infection (1930)

Event Date 06/23/2023

Event Type  Injury  

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 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.

• Brand Name: HUMERAL SPACER 33+6MM
• Type of Device: 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
• MDR Text Key: 319476661
• Report Number: 1220246-2023-07234
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00888867406902
• UDI-Public: 00888867406902
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221232
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 06/26/2023
• Date Device Manufactured: 05/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1