MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS HUMERAL STEM, SIZE 8; SHOULDR PROSTH HEMI- HUM UNCEM

Model Number UNIVERS REVERS HUMERAL STEM, SIZE 8

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Unspecified Infection (1930)

Event Date 01/08/2024

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

On 1/9/2024, it was reported on case number (b)(4) by a sales representative via (b)(4), that a revision reverse tsa procedure occurred on (b)(6) 2024 for unknown reasons.During the procedure, it was reported that an ar-9545-t15-01 driver shaft was stripped when trying to remove screws from the mgs baseplate.The case was completed successfully, with no reported patient harm and no further information provided.No pieces broke inside the patient.Additional information has been requested on what caused the necessary revision surgery on (b)(6) 2024 on (b)(4) for case number (b)(4).Additional information was received on 1/31/2024: on 1/9/2024, it was reported by a sales representative via (b)(4) that a patient had undergone a revision reverse tsa procedure on (b)(6) 2024 , due to an infection.All components had to be removed, and the suture cup had to be separated from the stem for explantation.The original procedure was performed on (b)(6) 2023 at the same facility.No new products were implanted after explantation.The case was completed using another ar-9545-t15-01 driver shaft to remove the suture cup.The surgeon stated the patient's current health status had been reported as good.

• Brand Name: UNIVERS REVERS HUMERAL STEM, SIZE 8
• Type of Device: SHOULDR PROSTH HEMI- HUM UNCEM
• 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: 18623994
• MDR Text Key: 334333439
• Report Number: 1220246-2024-00674
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00888867250406
• UDI-Public: 00888867250406
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161782
• 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: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNIVERS REVERS HUMERAL STEM, SIZE 8
• Device Catalogue Number: AR-9501-08P
• Device Lot Number: 22.02254
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2022
• 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
• Patient Outcome(s): Other